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Nov 27

Global Weight Loss Stomach Pump Market 2019 by Manufacturers, Regions, Type and Application, Forecast to 2025 – Global Market News 24

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Global Weight Loss Stomach Pump Market 2019 by Manufacturers, Regions, Type and Application, Forecast to 2025 - Global Market News 24


Nov 19

Keto and Intermittent Fasting: Should You Combine the Two? – Men’s Health

Ayman-AlakhrasGetty Images

Given the popularity of the ketogenic diet and intermittent fasting on their own, its no wonder that some people are trying both of these diets together. The two eating patterns share some similarities, so it has us wondering: is it more effective to combine them?

First, a quick reminder on what each is and does:

The ketogenic diet limits carbs to around 20 to 50 grams per day, depending on the person. Its high in fat70 to 80 percentand moderate in protein, around 25 percent of calories. The diet has been used to treat epilepsy in children, and has recently seen an astronomical growth trajectory in terms of followers, probably due to the fact that it works well for weight loss. At least, in the short-term.

The research behind keto in adults is mostly short-term, but suggests that maintaining this diet can have a positive impact on weight, triglycerides, and blood glucose.

Intermittent fasting is an eating pattern that involves relatively long periods of fasting, interspersed with windows of feeding. This way of eating has several formats, the most popular being 8/16, which entails a daily 16-hour fast and 8-hour feeding window. IF has mostly small-scale human and animal research behind it, with some of those studies suggesting that its effective for weight loss, reducing cholesterol, and decreasing insulin resistance.

Given the efficacy of both these eating patterns, doing keto and IF together seems like an attractive prospect. There are pros and cons.

Replacing carbs with fat on a keto diet causes appetite to decrease, possibly due to shifts in appetite-regulating hormones. Once youre fat-adapted on the keto diet and your appetite is lower than normal, youll probably find the fasting portion of IF easier.

The controlled calories from the short feeding window, plus the fact that youre using fat for energy, may mean that you may lose more weight in a shorter period of time. While this can be a benefit for those looking to lose weight, research suggests that weight loss from IF and keto may not be any better in the long term compared to a low-calorie diet.

The ketogenic diet restricts carbs so the body switches to fat for fuel. At the same time, fasting causes the bodys glycogen levels to deplete, so the combination of the two diets together is like a fast-track to ketosis. This can help mitigate the "keto flu," a particularly nasty symptom of the transition into ketosis.

Done wrong, keto can still be unhealthy, and IF doesnt change that. Unlike what many people perceive it to be, the ketogenic diet isnt meant to be full of cheese, eggs, and bacon. To help avoid increases in LDL cholesterol, the keto diet should be based on mostly unsaturated fats from sources such as avocados, nuts, and olive oils.

SCIENCE PHOTO LIBRARYGetty Images

While IF may help reduce fat stores while preserving muscle mass, the extremely low carb level of the ketogenic diet has been shown to negatively affect athletic performance. This may not be the case with everyone, but carbohydrates, not fat, are still considered to be the best source of fuel for athletes.

Its a lot of restriction. Most people would consider the ketogenic diet fairly restrictive on its own, with its extremely low carb limits. In fact, because of the level of restriction, most people cant stick to very low carb diets for the long term. Adding a layer of time constraints on top of the keto diet may be too much to handle. And the benefits of these diets are present only during the time that youre on them; they tend to disappear once you go back to your normal eating habits.

Combining keto and IF may be effective for some people, but in this case, more might not be better. The overall level of restriction of doing both diets together may be overwhelming, and because each diet has been shown to be effective on its own, theres no compelling reason to combine them, especially if doing so will impact your ability to maintain this style of eating for the long-term.

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Keto and Intermittent Fasting: Should You Combine the Two? - Men's Health


Nov 19

A Handle on your Health: Intermittent Fasting – San Marcos Daily Record

I am no fan of diets. Most diets can work, for a while, but most people tend to yoyo up and down with dieting. They apply themselves for a while but soon they fall back into old habits. It can be difficult to alter the types of food you eat for long term and so many diets are hard to sustain. How are you going to make the change to a high protein low carbohydrate keto diet when you love spaghetti and fettuccine? Well maybe intermittent fasting may be your answer because it doesnt tell you what to eat but rather when to eat.

Intermittent fasting (IF) actually has lots of good research to support it, unlike some other diets. If you think about it, we humans lived a fasting lifestyle in our early history. We were hunter-gatherers so food wasnt readily available to us like it is now. While popular press has made intermittent fasting more well known over the last 5 years, the research into it goes back decades. Sure, most of this research involves rats and mice but the results are very good.

The study results in humans for weight-loss with intermittent fasting are good but really no better than any other diet. Whether youre doing the Atkins diet or Weight Watchers or South Beach or intermittent fasting (IF) everyone loses weight. The cool thing with IF is that it has benefits to your health that go beyond just weight loss. To understand some of these benefits we need an understanding of what IF does at the cellular level to our bodies.

For IF to work we need our bodies to enter a state of catabolism where it is breaking down stored energy sources (fat) and using them up to run our metabolism. So you have to fast long enough to induce the bodys machinery to convert over to catabolism.

There are several ways this can be done. The most popular seems to be the 16:8 model, where you eat only during an 8-hour period in the day. Some people prefer to fast for 24 hours two days out of the week. Either option will cause the body to lower its insulin level, which is key for IF to work.

When you eat food, especially carbohydrates, your body releases insulin which is a hormone that tells your cells to bring sugar (glucose) into the cells for energy but when you dont eat for awhile your insulin level goes down and your cells instead get a signal to stop bringing sugar in and instead cut up stored fats for energy.

One concern for people trying to lose weight is muscle loss. Anytime you begin a diet to lose weight you are at risk of also losing some muscle. With intermittent fasting, however, Human Growth Hormone (HGH) levels actually go up. Elevated HGH levels send signals to cells to burn fat but also to build muscle. So for you gym rats out there, IF may be a better way to eat for you instead of eight small meals a day, which is time consuming to plan and make. If you do work out on an IF diet, you may want to supplement yourself with some branched chain amino acids before your workouts.

Norepinephrine also gets released with IF which acts to stimulate your metabolism and produce more weight loss. IF also acts to release the brain hormone BDNF which acts to encourage the growth of new neurons and synapses which may help in brain function. Studies are being done to see if this can help reduce the occurrence of Alzheimers disease. Heart health may be improved too, as LDL (bad cholesterol) levels are lower with IF as is blood pressure. Insulin resistance, which is the main problem in type II diabetics, is improved significantly with IF. Rats also showed to live longer (36-83% longer) on an IF diet plan. For us humans that could mean instead of dying at 80, you would make it to the ripe old age of 146. Honestly not sure if I want to live that long.

Who should be careful with this style of eating? Advanced diabetics, children, people suffering with bulimia or anorexia and pregnant women should probably avoid IF. In fact, women as a group do not benefit as much from IF as men do. If youre trying to get pregnant IF can disrupt normal menstrual cycles.

When is the best time of the day to fast? A better question is when can I eat? An Alabama study found that eating between the hours of 7a.m. and 3 p.m. (circadian rhythm eating) produced the best results. Nighttime eating, as a general rule, produces more obesity.

IF has also been found to be sustainable. Once you get through the transition and become used to feeling hungry part of the day, this diet can be continued throughout your lifetime. You still get to eat the things you enjoy eating and as long as you dont gorge yourself at mealtimes you will maintain or lose weight. You should still be picking healthy food, though, and staying away from processed carbohydrates and sugars.

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Dr. John Turner is a family medicine and emergency medicine doctor with 25 years of experience. He is also the owner of My Primary Care Clinic and My Emergency Room 24/7 here in Hays County. Dr. Turner may be reached at 512-667-6087.

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A Handle on your Health: Intermittent Fasting - San Marcos Daily Record


Nov 19

‘I Lived By The 80-20 Rule And Took Up Strength TrainingAnd I Lost 70 Pounds’ – Women’s Health

Hi! My name is Briana Shaffer (@brianakfitness), 25, and I'm from Carlsbad, California. I'm the CEO and owner of a fitness apparel corporation (check it out at @brianakcollection). A personal tragedy led to a period of weight gain for me, but after a wakeup call moment I decided to change my lifestyle and lost 70 pounds in the process.

After my best friend died in a car accident, it turned my world upside down. I gained 70 pounds and became depressed. My doctor told me if I didnt make a lifestyle change, I could end up having even more serious health issues down the line.

So I finally said enough was enough. And in September of 2015, I start logging everything that I was eating, a suggestion from my doctor. I was 190 pounds at only 5-feet, 4-inches when my weight-loss journey began.

I started meal prepping and followed the 80/20 rule with my diet: 80 percent of my diet was nutritious, healthy foods, and 20 percent was treats. The 80/20 style of eating has worked best for me because I am able to still enjoy the treats I love here and there, rather than only eating healthy all day every day, which isn't always sustainable. What didnt work was trying to eat chicken and broccoli every single day.

The 80/20 rule has also helped keep me from binging over the weekend. If I let myself have a cookie or a decadent, special meal during the week, I'm not looking ahead at the weekend like this rare time I have to go crazy. It's all about balance.

The 80/20 diet (although you really don't even have to think of it as a diet at all!) is also more maintainable for my lifestyle. I am still able to go out with family and friends without feeling anxious about what to eat.

Eventually, I got a gym membership and started lifting weights five times a week. Strength training helped me cope with the death of my best friend, and after every single workout, I felt stronger, happier, and more confident.

My workout schedule is currently: two full-body days, two leg days, and one arm day. I also decided that its not best for me to weigh myself. Im all about non-scale victories. Instead, I go off progress photos and how my clothes fit.

Fitness is so overwhelming, and I think people complicate it. Ive always taken it one step at a time with working out and my diet. I didn't just wake up one day able to work out five days a weekit took time and practice.

I also had to learn to let go of guilt. If you slack off one day, dont beat yourself up. Start fresh the next day. Feeling guilty will only hurt you and your progress. It's important to be kind to yourself and appreciate even those small accomplishments. You should be doing this because you love your body and want to put it first. Be proud of those baby steps that will eventually add up to the bigger goal.

You dont need supplements, weight loss teas, and pills. You dont have to give up food that you love or miss out on functions. Its all about finding that balance.

It took me two years to lose the weight. Starting my health and fitness journey changed my whole life. It helped my self-confidence in addition to my physical health. It has also helped me build a solid foundation to continue working out long term. And honestly. the biggest change has been on my mental health.

Fitness gave me a platform to help other women achieve the same self love that I now have. Fitness also opened up the doors to me now running my own company and doing what I love every single day.

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'I Lived By The 80-20 Rule And Took Up Strength TrainingAnd I Lost 70 Pounds' - Women's Health


Nov 19

Long-term, intermittent fasting increases survival rate of heart patients, Utah researchers say – KSL.com

SALT LAKE CITY Long-term, routine fasting improves survival rates for cardiac catheterization patients, according to a new study by Intermountain Healthcare.

The study conducted at the Intermountain Healthcare Heart Institute involved 2,001 participants who answered lifestyle questions and were followed for nearly five years to see how long they survived and whether they experienced serious heart events or death, said Dr. Benjamin Horne.

Horne served as principal investigator of the study and is the director of cardiovascular and genetic epidemiology at the institute.

We found that people who said they routinely fasted had a much lower death rate. Their survival was higher, and they also, in conjunction with that, had a lower incidence of heart failure. So we are finding there may be some greater survival among people who fast routinely, Horne explained.

He said the institute had been studying the effects of fasting for several years, but wanted to perform a long-term study with a larger group. The results were presented Saturday at the 2019 American Heart Association Scientific Sessions in Philadelphia.

Those in the participant group considered routine fasters had been fasting for at least 42 years, or two-thirds of their lives.

Its a long period of time. Its not a quick fix, rapid weight loss diet that they were following. Most of them, of course, were fasting for religious purposes, Horne said, pointing to a practice among members of The Church of Jesus Christ of Latter-day Saints, who fast on the first Sunday of every month, usually for two meals.

That group experienced higher survival rates than non-fasters, Horne said, as they lived about a year longer on average.

A study from the 1970s and 1980s found a higher survival rate among observant members of the church compared to the rest of the populations of California and the U.S., Horne said.

Additionally, Utah, according to the American Heart Association, has one of lowest cardiac mortality rates in the country, a consistent finding for decades, he said.

One of the exciting things about this study is it potentially links this factor this behavior of fasting, that has a known connection to biology and better health it links it to this survival effect that others have found. But theyve just linked it to people who had the Latter-day Saints religious preference. Now this links it to a specific factor, a specific behavior, in fasting, he said.

The researchers in the new study corrected for lifestyle factors like smoking. Most members of the church do not smoke.

Its not a quick fix, rapid weight loss diet.

Doctors believe those who had fasted routinely had a higher survival rate because their bodies have experienced long years of conditioning. During a one-day fast, their bodies activate the benefits of fasting earlier than an average person, Horne said. For an average person, benefits usually start about 12 hours into fasting period.

We think that this routine fasting for years and decades is conditioning the body to activate the benefits of fasting at eight or 10 hours, and then an overnight fast youre getting some of the benefits on a daily basis for your lifespan. And that would have a profound impact, Horne explained.

One group of participants was made up of new fasters, those who had been fasting for less than five years. On average, the group had fasted for nine months. Horne said they did not experience a higher survival rate, and instead had potentially worse survival rates than those who didnt fast at all.

Based on the research, Horne cautions people who want to begin fasting to consider doing so in a rational, wise manner, as rapid weight loss diets that include fasting can be taken to extremes.

We want people to realize there are other things they can do like exercise and eating a good diet, and reducing cholesterol and blood pressure, that are important also for health, he explained.

Some people shouldnt fast, including young children, older adults who are frail, people who have organ transplants or chronic diseases, and women who are pregnant or breastfeeding. Those with chronic diseases should talk to their doctors before they begin fasting, Horne said.

But he said the biggest takeaway from the study is for people who are fasting right now keep doing it. If theyre doing a fasting regimen, it should be long-term to receive the benefits for their heart health, according to Horne.

I think the central message is that we found that fasting appears to protect humans from heart failure, and that leads to better survival, he said.

Intermountain is continuing its research on fasting. Horne believes laboratory studies will be needed to figure out the mechanisms that fasting triggers, as well as interventional studies among people to see which groups can benefit the most from fasting, and potential safety issues.

The Beehive State is a fabulous place for these studies because theres a large population who fast routinely for religious purposes, Horne said.

This is a study that probably could not be done in any other place in the world right now, or very few other places, and it would be something that would require a lot more resources in those other locations to be able to find people who fast on a routine basis and have done so for decades, he said.

Horne also thanked Intermountain Research and Medical Foundation for funding the study.

Continued here:
Long-term, intermittent fasting increases survival rate of heart patients, Utah researchers say - KSL.com


Nov 19

Weight loss: Fried chicken addict ate nothing but KFC for a week and LOST weight but its not all good new – The Sun

A FRIED chicken addict ate nothing but KFC for a week - and ended up losing weight.

Mike Jeavons loves the greasy fast food and wanted to see if he still enjoyed the meal if he had it seven days straight.

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In a "Super Size Me" style experiment, he travelled to his local KFC in Bedfordshire on a daily basis to try out every item on the menu.

The 34-year-old spent 105 over the whole week and consumed an average of 2,000kcal every day.

He was surprised to step on the scales at the end of the "experiment" and find out he had lost 2lbs.

However, it wasn't all good news as his salt intake increased to 150 per cent of his recommended dietary allowance and his fat intake increased to a whopping 250 per cent.

Mike said: I love KFC and wanted to see if Id still love it if it was all I ate for a week.

After I stopped the experiment, the week after I felt constantly thirsty and had headaches. I also really missed KFC.

Its great as an occasional treat, but not something Id recommend eating every day

It was a lot of fun eating all this naughty food. Every day I would be really looking forward to mealtimes.

Its great as an occasional treat, but not something Id recommend eating every day. It was fun to do but I wouldnt want to do it again."

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Ingredients such as salt, sugar and fat are sometimes added to processed foods to make their flavour more appealing and to extend their shelf life.

But this can lead to people eating more than their recommended amounts as they may not be aware of how much has been added to the food they are buying and eating, according to the NHS.

Experts warn that regularly consuming foods and drinks high in sugar increases your risk of obesity and tooth decay.

Obesity has been linked to 13 different types of cancer, as well as diabetes,heart diseaseand stroke.

Dietitian Helen Bond said: "If you are obese you are more at risk ofobesity related cancers, you are more at risk of heart diseaseand stroke.

"And also the fat content within junk food is quite high insaturated fats and trans fatsand they can increase the risk of bad cholesterol and over time that is not good news for yourheart health.

"Obesity is also linked to insulin resistance, pre-diabetes and also type 2 diabetes.

"In the long-term we know too much salt can cause raises in blood pressure."

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On top of that, junk food doesn't contain anywhere near as much fibre as you need to maintain a healthy gut.

"If your diet is very heavily reliant on junk food then it is very difficult to get the 30g of fibre recommended per day," Helen added.

"Your gut bacteria needs food that is nourishing and we are learning more and more about the importance of gut health in relation to things like immunity, to weight to digestive issues.

"For people that have digestive issues where absorption [of vitamins and minerals] is a problem then making sure your gut is as healthy as possible goes hand-in-hand with a high fibre diet.

"There are some people with issues likeirritable bowel syndrome(IBS) where a high fibre diet may cause them problems, but generally people should be eating more of it in our diet."

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FAT FIGHTER Size 32 woman sheds staggering 10st and looks like a totally different person

FAT FUNDAMENTALS Best ways to blast belly fat fast WITHOUT giving up carbs

BREAK THE FAST Top tips to maximise fat burning first thing - & best breakfasts for dieters

IT'S THINFLUENZA Trendy low-carb diets promoted by celebs 'protect against the flu'

WE CAN WORK IT OUT I was so fat I had to quit my job - after years of gorging on takeaways

'BLESSING IN DISGUISE' Bride-to-be shed 35st after docs cut off her TONGUE to treat cancer

AISLE SAY! I lost 6st after wearing a size 22 wedding dress & being asked if I was pregnant

DIET DOS & DON'TS Millions of Brits clueless about healthy diets and portion size

AISLE BE DAMNED Mum sheds 6st to fit into wedding dress - after gorging on bags of cheese

Obesity levels in the UK have trebled in the last 30 years and about 27per cent of the UK population is considered obese.

A further 34 per cent are considered overweight, according to thelatest Government statistics.

We are officially the fattest nation in Europe - with obesity costing the NHS about 16bn a year.

Top 10 tips to overcome unhealthy cravings

These 10 top tips can help you overcome unhealthy cravings, or dependence on ultra-processed foods, and effectively create your own healthy meal plans:

Source: OurPath

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Weight loss: Fried chicken addict ate nothing but KFC for a week and LOST weight but its not all good new - The Sun


Nov 19

Fractyl’s intestine-resurfacing device shows gains in HbA1c and liver fat, plus 2-year data – FierceBiotech

Fractyl Laboratories presented new data from two trials of its intestine-resurfacing procedure, including one demonstrating improvements in both blood glucose control and liver fat among Type 2 diabetes patients with and without nonalcoholic fatty liver disease.

The second study illustrated durable benefits in HbA1c reduction for up to two years after a single outpatient treatment. The former Fierce 15 winners endoscopic Revita device and procedure uses water and heat to strip away the inner lining of the small intestines duodenum, allowing it to regrow naturally.

That mucosal lining can thicken after years of exposure to dietary fats, sugars and other foods. The company believes its rejuvenating process can reset the balance of hormones produced within that part of the organ, many of which are linked to metabolic pathways and related diseases as well as insulin resistance.

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Fractyls first multicenter, sham-controlled clinical study tested a procedure that ablated a length of 10 centimeters within the duodenum, across the organs entire inside circumference. For the two weeks following, patients received a controlled diet that escalated from liquids to semi-solids to solid foods.

After 24 weeks, the Revita procedure showed a reduction of 0.8 percentage points in HbA1c and a 32% reduction in liver fat content measured by MRI.

RELATED: Fractyl's intestine-resurfacing procedure shows people with Type 2 diabetes going insulin-free for 6 months

Meanwhile, patients with a higher fasting plasma glucose at the studys baseline saw a 1.2% reduction in HbA1c, and improvements in weight loss, liver insulin sensitivity and pancreatic beta-cell function were also observed, the company said. The results were presented in a late-breaking oral presentation at the annual meeting of the American Association for the Study of Liver Disease in Boston.

The second, long-term study, presented at the Diabetes Technology Meeting in Bethesda, Maryland, showed a full percentage point reduction in HbA1c after two years, from 8.5% to 7.5%, among 34 patients with Type 2 diabetes.

RELATED: Fractyl Labs ropes in $44M in series D funding for balloon ablation device for Type 2 diabetes

Improvements in liver biomarkers were also seen over the same period, Fractyl said, alongside an 80% response rate. Additionally, patient satisfaction scores were improved at 12 months, and no adverse events attributed to Revita were observed, the company said.

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Fractyl's intestine-resurfacing device shows gains in HbA1c and liver fat, plus 2-year data - FierceBiotech


Nov 19

Sipping water throughout the day is the key for weight loss, says new research – Wales Online

The dreaded middle age spread is often inevitable - but new research claims by drinking litres of water, you can stop it in its tracks.

Regular sips throughout the day can help those hoping to slim down shed the pounds by boosting metabolism, say scientists.

As well as burning up calories, it helps with hunger pangs as well as cleansing the body of waste.

Research shows it is the most commonly reported dieting tool - more than three times as popular as eating less food and over twice as preferred as exercise.

Corresponding author Professor Lu Qi, a nutritionist at Tulane University in the United States, said: "Our analysis revealed an increasing trend in the use of increased water consumption as a weight loss strategy.

"This increase can be attributed to convincing evidence regarding the potentially important role of water in reducing energy intake, which thus contributes to the long term maintenance of weight loss."

The findings, published in JAMA Network Open, are based on data collected from about 48,000 men and women aged 40 to 64.They were participants in the continuing National Health and Nutrition Examination Survey (NHANES) who were followed for up to 17 years.

Among those with a BMI (body mass index) of at least 25 who considered themselves overweight, almost four in ten (38%) tried to slim by "drinking a lot of water," said Prof Qi.

On the other hand, fewer than a fifth (18 per cent) chose exercise and one in nine (11 per cent) eating less.

Experts say if you are constantly dehydrated, your body tends to retain more water in an attempt to prevent levels getting too low.

It is important for liver and kidney health, too.

Guidelines suggest about two litres per day. Urine colour is a good indicator.

If it is light yellow or fairly clear this is a sign of being well hydrated.

Dark yellow or amber means you need more water. Over the study period from 1999 to 2016 current individual BMI increased by an average of 20 per cent and weight by 6lbs (2.77 kilos), underlining the growing obesity epidemic.

Prof Qi said: "These increases were observed despite increases in the proportion of participants who attempted to lose weight and used weight loss strategies, such as reducing food consumption, exercising and consuming a large volume of water."

The proportion who had attempted to lose weight increased from around a third (34%) at the start of the study to more than four in ten (42%) by the end.

Prof Qi said: "Social pressure associated with an acceptable body weight and size might contribute to the increased reporting of weight loss attempts."

He added: "Taken together, these findings suggest that although 34 per cent to 42 per cent of adults in the United States in our study reported weight loss efforts, many of them might not have actually implemented weight loss strategies or applied a minimal level of effort, which yielded unsatisfactory results."

The proportion of participants who reported consuming more fruits, vegetables and salads, changing their eating habits, consuming less sugar, confectionery and junk food increased sharply.

Prof Qi said: "Evidence from other studies has shown these changes to be associated with less weight gain and, therefore, these strategies would be encouraged.

"Existing guidelines and compelling evidence also suggest longitudinal weight management relies on a combination of reductions in energy and fat intake, an increase in dietary fibre intake, regular physical activity, self monitoring, and other behavioural techniques.

"Reduction of either carbohydrates or fat has been similarly related to weight loss, especially in the context of low-calorie diets."

The prevalence of obesity among US adults increased from 34 to 40 percent between 2007 and 2016. Around a third of adults in the UK are obese.

Prof Qi added: "Obesity is associated with a variety of major chronic diseases, including cardiovascular disease, type 2 diabetes and cancer, as well as premature mortality.

"Compelling evidence suggests that even moderate weight loss significantly reduces the risk of obesity-related diseases and mortality.

"However, losing weight and maintaining a healthy weight remain significant challenges.

"Earlier this year Hollywood star Chris Pratt revealed he lost almost a stone by "drinking water and weeing three times before 10am."

The 40-year-old actor once tipped the scales at a gut-busting 21 stone. He shed over five stone for the role of hunky Peter Quill in Guardians Of The Galaxy.

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Sipping water throughout the day is the key for weight loss, says new research - Wales Online


Nov 19

How to boost recycling: Reward consumers with discounts, deals and social connections – Arizona Daily Star

You finish that last sip of morning coffee and stare at the empty paper cup in your hand. Should it go into the recycling bin, compost, or be landfilled or incinerated?

Research shows that more often than not, Americans give up trying to sort their recyclables. Or they engage in wishful recycling, tossing nonrecyclables into the bin. Even so, most waste never gets that far. People feel intimidated by the task.

The average American generates about 4.5 pounds of waste each day. Only 1.5 pounds of it is recycled or composted. This means that over an average lifetime of 78.7 years, one American would send 67,000 pounds of waste to landfills. Thats more than twice the weight of a cruise ship anchor.

Scrap materials are piling up at U.S. recycling centers that no longer can ship them to China. AP Photo/Charles Krupa

Although many communities and advocates have adopted regulations and action plans centered on moving toward a circular economy, major barriers still make it hard for individuals to reduce, reuse and recycle. Existing policies have been developed based on insights from engineering and economics, and give little consideration of how human behavior at the individual level fits into the system.

Why recycling is so hard

Why is getting Americans to recycle more so challenging? First, many of them dont understand waste problems and recycling strategies. Few are aware of the environmental problems waste causes, and most have a hard time connecting individual actions to those problems.

Most people dont know where their waste goes, whether it includes recyclables or what can be made from them. They may know what day to put out curbside trash and recycling, but are unsure which materials the companies accept. In a 2019 survey of 2,000 Americans, 53% erroneously believed greasy pizza boxes could be recycled, and 68% thought the same for used plastic utensils.

Another 39% of respondents cited inconvenience and poor access to recycling facilities as major barriers. California pays a 5- to 10-cent redemption fee for each beverage container, but the facilities often are inconvenient to reach. For example, the closest to my home in Los Angeles is eight miles away, which can involve driving for an hour or more. Thats not worth it for the few cans my family produces.

Most U.S. consumers are opposed to pollution, of course, but research shows that they seldom view themselves as significant contributors. As taxpayers, they hold local governments responsible for recycling. Many are not sure what happens next, or whether their actions make a difference.

Motivation matters

What can be done to address these barriers? Better messaging, such as emphasizing how waste can be transformed into new objects, can make a difference.

But as I argue in my 2018 book, The Green Bundle: Pairing the Market With the Planet, information alone cant drive sustainable behavior. People must feel motivated, and the best motivations bundle environmental benefits with personal benefits, such as economic rewards, increased status or social connections.

In a 2014 survey, 41% of respondents said that money or rewards were the most effective way to get them to recycle. Take-back systems, such as deposits on cans and bottles, have proven effective in some contexts. Such systems need to be more convenient, however.

Returning bottles directly to stores is one possibility, but novel strategies are being deployed across the country. Pay-as-you-throw policies charge customers based on how much solid waste they discard, thus incentivizing waste reduction, reuse and more sustainable purchasing behavior. Recyclebank, a New York company, rewards people for recycling with discounts and deals from local and national businesses.

Status and support

Social status also motivates people. The zero-waste lifestyle has become a sensation on social media, driving the rise of Instagram influencers such as Bea Johnson, Lauren Singer and Kathryn Kellogg, who are competing to leave behind the smallest quantity of waste. Visibility of conservation behavior matters, and could be a powerful component in pay-as-you-throw schemes.

Its also nice to have support. Mutual help organizations, or community-led groups, trigger behavioral change through social connections and face-to-face interactions. They have the potential to transfer empowering information and sustain long-term commitment.

One famous example is Alcoholics Anonymous, which relies on member expertise instead of instructions from health care specialists. Similarly, Weight Watchers focuses on open communication, group celebration of weight loss progress and supportive relationships among members.

French startup Yoyo, founded in 2017, is applying this strategy to recycling. Yoyo connects participants with coaches, who can be individuals or businesses, to help them sort recyclables into orange bags. Coaches train and encourage sorters, who earn points and rewards such as movie tickets for collecting and storing full Yoyo bags.

The process also confers status, giving sorters positive social visibility for work that is ordinarily considered thankless. And because rewards tend to be local, Yoyos infrastructure has the potential to improve members community connections, strengthening the perceived and actual social power of the group.

This system offers a convenient, social, incentive-based approach. In two years the community has grown to 450 coaches and 14,500 sorters and collected almost 4.3 million plastic bottles.

Such novel behavior-based programs alone cannot solve back-end aspects of the global waste crisis, such as recycling capacity and fluctuating scrap material prices. But our research has shown that by leveraging technology and human behavior, behavioral science can encourage people to recycle much more effectively than simplistic campaigns or slogans.

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How to boost recycling: Reward consumers with discounts, deals and social connections - Arizona Daily Star


Nov 19

Inflammatory Bowel Disease Insight Report: Current Therapies, Drug Pipeline and Outlook – BioSpace

Inflammatory bowel disease (IBD) is an umbrella term for two conditions, Crohns disease and ulcerative colitis, that are characterized by chronic inflammation of the gastrointestinal (GI) tract. This chronic and prolonged inflammation results in damage to the GI tract.

Historically IBD has been predominantly seen in industrialized countries, with the highest reported prevalence values in Europe and North America. In the United States alone, approximately 1.6 million people currently have Crohns disease or ulcerative colitis, and as many as 70,000 new cases of IBD are diagnosed each year. Although the incidence of IBD in North America and Europe is currently reported to be stabilizing or decreasing, the burden remains high as prevalence exceeds 03%. Over the last 30 years, the predominance of IBD has accelerated in newly industrialized countries including Africa, Asia and South America. Reports of IBD appear to be higher in urban areas than in rural areas, as well as in higher socio-economic classes. Individuals who immigrate to industrial urbanized developed nations before adolescence and those immigrants who initially belonged to a low-incidence population show a significantly higher incidence of IBD. This rise has been attributed to the rapid modernization and westernization of the population.

The reported rise in the number of people living with inflammatory bowel disease reflects a need for more research to find a cure. This article explores current therapies, drugs in the pipeline and disease outlook for patients and their caregivers living with IBD.

Overview

Inflammatory Bowel Disease is a broad term that describes conditions characterized by chronic inflammation of the gastrointestinal tract. The GI tract is responsible for the digestion of food, absorption of nutrients and elimination of waste. Inflammation impairs the ability of affected GI organs to function properly, leading to symptoms such as persistent diarrhea, abdominal pain, rectal bleeding, weight loss and fatigue. The two most common inflammatory bowel diseases are Crohns disease and ulcerative colitis.

Causes:

The exact cause of IBD is not entirely understood, however, it is known to involve an interaction between the immune system, genes and environmental factors.

In people with IBD, the immune system mounts an inappropriate response to the intestinal tract, resulting in inflammation. This abnormal immune system reaction occurs in people who have inherited genes that make them susceptible to IBD. Unidentified environmental factors serve as the trigger that initiates the harmful immune response in the intestines.

Studies have shown that 5 to 20% of affected individuals have a first-degree relative (parent, child or sibling) with one of the diseases. Numerous genes and genetic mutations connected to IBD have been identified including a mutation in the NOD2/CARD15 gene. Up to 20% of IBD patients in North America and Europe may have a mutation in the NOD2/CARD15 gene. While genetic testing is possible, it is not currently a part of the diagnostic process for IBD. Genetic testing can identify a potential risk for IBD in an individual but cannot predict whether IBD will develop.

The environmental factors that trigger IBD are not known, but several potential risk factors have been studied. These include smoking, use of antibiotics, use of Nonsteroidal anti-inflammatory drugs, diet and geographic location (more prevalent in industrialized countries).

Life expectancy: People with Inflammatory Bowel Disease have a relatively normal life expectancy compared to the general population. However, people with Crohns disease have a slightly higher overall mortality rate than the general healthy population. The increase in deaths is largely due to conditions such as cancer (particularly lung cancer), chronic obstructive pulmonary disease, gastrointestinal diseases, (excluding Crohns disease), and diseases of the genital and urinary tracts. In addition, patients with extensive inflammation in the colon due to ulcerative colitis are at higher risk than the general population for dying from gastrointestinal and lung diseases.

Annual Cost: There are both direct and indirect costs associated with IBD. Direct medical costs include expenses for hospitalizations, physician services, prescription drugs, over-the-counter drugs, skilled nursing care, diagnostic procedures and other healthcare services. Indirect costs are the value of lost earnings or productivity. Indirect costs also include the value of leisure time lost.

Direct Costs: The annual direct cost of Crohns disease is estimated to be from $8,265 per patient to $18,963 per patient and the annual direct cost of ulcerative colitis is estimated to be from $5,066 per patient to $15,020 per patient. Extrapolating from this data to the current prevalence estimates of IBD (780,000 cases of Crohns disease and 907,000 cases of ulcerative colitis), the total annual direct costs for all patients with IBD in the United States is estimated to be between $11 billion to $28 billion.

Indirect Costs: Based on a national health survey in 1999, nearly 32% of symptomatic IBD patients reported being out of the workforce in a one-year period, incurring an indirect cost of an estimated $5,228 per patient, bringing the total indirect cost of IBD in 1999 to $3.6 billion.

Diagnostic Strategies

One or more of the following tests or procedures may be used to help confirm a diagnosis of IBD.

Blood tests to check for anemia or infection from bacteria or viruses. A fecal occult blood test may also be used to test for hidden blood in the stool. Although a blood test cannot confirm the presence of IBD, it can help rule out conditions that cause similar symptoms.

Endoscopic procedures such as colonoscopy, upper endoscopy, sigmoidoscopy, and capsule endoscopyare also used to diagnose IBD. These procedures provide clear and detailed views of the gastrointestinal tract and can help to differentiate between Crohns disease and ulcerative colitis.

Imaging testssuch as X-rays, CT scans, and MRI scans are often used in conjunction with endoscopic procedures. Imaging data can reveal signs of IBD in the lining of the intestines, such as tears, bleeding, inflammation, or an obstruction.

Current Therapies

There is no cure for IBD. The goal of treatment is to reduce the inflammation that triggers the signs and symptoms, thus providing relief as well as long-term remission and reduced risks of complications. IBD treatment usually involves either drug therapy or surgery. Classes of medications used to treat IBD include anti-inflammatories, immunosuppressants, biologics and antibiotics.

Anti-inflammatory drugs are often the first step in the treatment of inflammatory bowel disease. Anti-inflammatories include corticosteroids and aminosalicylates (5-ASA), such as Allergans mesalamine (Asacol HD, Delzicol, others), Salix Pharmas Colazal (balsalazide) and Uceris (budesonide) and AstraZeneca's Entocort EC.

Immune system suppressor medications are used to stem the immune response that releases inflammation-inducing chemicals in the intestinal lining. Some examples of immunosuppressant drugs include azathioprine (Azasan, Imuran), mercaptopurine (Purinethol, Purixan), cyclosporine (Gengraf, Neoral, Sandimmune) and methotrexate (Otrexup, Rasuvo, Rheumatrex Dose Pack, Trexall, Xatmep).

Tumor necrosis factor (TNF)-alpha inhibitors, or biologics, are a group of medicines that suppress the body's natural response to tumor necrosis factor (TNF), a protein produced by white blood cells that is involved in early inflammatory events. Examples include AbbVie's Humira (adalimumab), Janssen's Simponi (golimumab), UCB's Cimzia and infliximab (Remicade, Inflectra). Other commonly used biologic therapies are Tysabri (natalizumab), Entyvio (vedolizumab) and Stelara (ustekinumab).

Antibiotics may be used in addition to other medications or when infection is a concern. Frequently prescribed antibiotics include ciprofloxacin (Cipro) and metronidazole (Flagyl).

Drug Pipeline

A variety of targeted therapies are currently being explored through clinical trials. In addition to TNF-alpha inhibitors, aminosalicylates and glucocorticosteroids, common targets and mechanisms include:

As of October 2019, there are 730 clinical trials (not yet recruiting/active/active, no longer recruiting) listed on clinicaltrials.gov. Of these trials, 268 are in the United States and the remainder are across global sites. When broken down by phase, there are 63 trials in phase I, phase II has 132 trials, 101 phase III trials and the remainder are in phase IV or are other types of studies, including behavioral modification or observational studies, those using dietary supplements and various devices.

The IBD market contains a mixture of big and smaller sized pharma and biotech companies. The market share is dominated by Janssen with 5 drugs in all phases (I-III) and Pfizerwith 5 drugs in phase I and II. The remaining companies include Roche in collaboration with Genentechwith three drugs in phases I-III and AbbVie with three drugs in phase II, II/III and III.

The following analysis of selected drugs in the pipeline will briefly discuss how each drug works and where it is in clinical trials. This information was up to date as of October 2019. Any text in italics represents failed or terminated trials.

Note: This section is not meant to be completely comprehensive and may unintentionally exclude some drugs in development or clinical trials, especially those trials outside of the United States.

Janssen has five drugs in development for IBD: golimumab, ustekinumab, JNJ-64304500 (JNJ-4500/ IPH-2301/NN-8555), JNJ-67864238, guselkumab monotherapy and guselkumab combined with golimumab.

Pfizer also has five drugs in development for both Crohns disease and ulcerative colitis.

This trial was suspended in July due to an interruption in the supply of the radiolabeled material.

A phase II trial is underway to determine if PF-06687234 is effective and safe as add-on therapy to infliximab in subjects with active ulcerative colitis who are not in remission.

Genentech/Roche has three treatments in development for IBD.

A phase I trial is evaluating etrolizumab in pediatric patients of 4 to <18 years of age with moderate to severe ulcerative colitis (UC) or with moderate to severe Crohn's disease (CD).

Genentechs Phase III Etro Studies program is also underway, assessing its safety and efficacy in both UC and Crohns. During this trial, etrolizumab will be compared to other currently the U.S. FDA-approved drugs, namelyRemicade (infliximab) and Humira (adalimumab), and to placebo. There are five planned trials for patients with UC, and two for thosewith CD, to be carried out in the U.S., as well as one non-U.S. based trial in UC patients. All these studies arecurrently recruiting participants.

AbbVie has three drugs in development for inflammatory bowel disease.

Phase I

Aevi Genomics has partnered with Kyowa Kirin for AEVI-002, a human monoclonal antibody that binds an inflammatory protein found in intestinal tissue called LIGHT. The trial is evaluating AEVI-002 for severe pediatric-onset Crohns disease. Initial data are expected in the second half of 2019.

Assembly Biosciences is conducting a phase IB clinical trial of its lead investigational live biotherapeutic product (LBP) candidate, ABI-M201, in patients with mildly to moderately active UC. ABI-M201 is comprised of a dened consortium of gut commensal bacterial strains, specically selected based on their functional attributes to target key aspects of disease biology. Assembly and Allergan have entered into a collaboration to jointly develop LBP compounds for Ulcerative colitis (UC), Crohns Disease and Irritable Bowel Syndromes. ABI-M201 is the first LBP candidate under this collaboration.

Enteromeis partnered with Takeda for the co-development and co-commercialization of EB8018 (TAK018), a first-in-class, non-systemic, orally administered small molecule. EB8018 is specifically designed to remain gut-restricted and to block bacteria expressing the bacterial virulence factor, FimH, a key inducer of the inflammatory cascade in the intestine, thereby decreasing intestinal inflammation in patients with Crohns disease. Preliminary data from a Phase Ib clinical trial of EB8018 for the treatment of Crohns disease is expected in 2019. Takeda is planning to commence a phase II trial in November of 2019.

Gossamer Bio is developing GB004, an oral HIF-1 stabilizer. Patient enrollment in a Phase Ib study of active mild-to-moderate ulcerative colitis (UC) began during the second quarter, and the Company expects topline results from the study in the first half of 2020.

Intralytix, Inc.'s EcoActive bacteriophage therapy targeting adhesive invasive E. coli (AIEC) in Crohn's disease patients has entered a Phase I/IIa clinical trial at the Icahn School of Medicine at the Mount Sinai Hospital in New York, NY. The presence of AIEC in the intestines is associated with worsening inflammation in this disease. The trial will measure the effect of oral phage administration on the AIEC (CFU/g) in stools of patients receiving phages versus patients receiving a placebo.

Nutrition Science Partners Limited, a 50/50 joint venture between Chi-Med and Nestl Health Science SA, is assessing HMPL004-6599, a proprietary botanical (Andrographis paniculate) with in vitro inhibitory activity against TNF-, IL-1 and NF-B. A pilot study of A. paniculata extract (HMPL-004) indicated similar efficacy to mesalamine for ulcerative colitis. HMPL004-6599 is an enriched/purified re-formulation of HMPL-004, an anti-inflammatory with anti-TNF properties. A phase 3 trial of the original formulation was evaluating its efficacy in ulcerative colitis. However, the trial was terminated in 2014 following an interim analysis showing the endpoint was unlikely to be reached.

OSE Immunotherapeutics has a pipeline of drugs aimed at immune-oncology and autoimmune diseases, one of which is OSE-127. OSE-127 is a monoclonal immunomodulatory antibody targeting the CD127 receptor, the alpha chain of the interleukin-7 receptor (IL-7R) that induces a powerful antagonist effect on effector T lymphocytes. The blockage of IL-7R prevents the migration of pathogenic T lymphocytes while preserving regulator T lymphocytes (1,2,3,4) which have a positive impact in autoimmune diseases. The first patients were dosed in a phase I trial in December of 2018.

Phase II

AbGenomicsis evaluating neihulizumab/AbGn-168H, a humanized therapeutic antibody with a unique mechanism of action, which preferentially induces apoptosis of late-stage activated T cells. This activated-T cell apoptosis-inducing antibody effectively eliminates chronic pathogenic T cells while fully maintaining host defense. A phase II trial is currently enrolling up to 40 patients with moderate to severe active ulcerative colitis and who have failed or are intolerant to anti-TNF and/or anti-integrin therapy.

Allergan's brazikumab is an anti-inflammatory with the potential to curb inflammation by blocking the proinflammatory molecule interleukin-23. In a double-blind, placebo-controlled study of 119 adults with moderate to severe CD who had failed treatment with tumor necrosis factor antagonists, 8 and 24 weeks of treatment were associated with clinical improvement. Higher baseline serum concentrations of IL22 were associated with a greater likelihood of response to treatment compared withplacebo.

Two trials are currently underway, and both are utilizing a personalized approach to evaluate the role of biomarkers, such as IL22, in predicting treatment response to brazikumab.

The phase II EXPEDITION trial is comparing brazikumab to placebo or Entyvio (vedolizumab) in approximately 375 patients with moderately to severely active ulcerative colitis.

The phase IIb/III INTREPID trial is currently enrolling up to 1,140 patients with moderate to severe Crohns disease to evaluate brazikumab versus placebo and versus an active comparator, Humira (adalimumab).

Boehringer Ingelheimis developing Spesolimab (BI 655130) is a monoclonal antibody that blocks the action of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system that may play a role in many inflammatory diseases. Proof of concept was demonstrated in a phase I study in patients with generalized pustular psoriasis, an IL36-mediated skin disease.

Four clinical trials are currently underway for both Crohns disease and ulcerative colitis.

Bridge Biotherapeutics is evaluating BBT-401, a GI-tract restricted small molecule inhibitor of Pellino-1. Pellino-1 is a ligase acting as a critical mediator for a variety of immune receptor signaling pathways, including Toll-like receptors, interleukin-1 receptor and T-cell receptors. BBT-401 was proved to be well-tolerated and safe in a phase I study in 80 healthy volunteers. In addition, the PK data demonstrated its key feature of no or minimal systemic exposure. A randomized, placebo-controlled, dose-escalation phase II trial is recruiting 48 patients with active ulcerative colitis.

Bristol-Myers Squibbs BMS-986165 is an oral, selective tyrosine kinase 2 (TYK2) inhibitor. TYK2, an intracellular signaling kinase, mediates cytokine-driven immune and pro-inflammatory signaling pathways that are critical in the cycle of chronic inflammation central to immune-mediated diseases. A phase II trial in patients with psoriasis was successfully completed in 2018. Two phase II trials are currently underway, one each in Crohns disease and ulcerative colitis.

Eli Lillyis progressing with mirikizumab (LY 3074828), a humanized IgG4 monoclonal antibody that binds and inhibits the p19 subunit of interleukin 23. Positive results have been reported from the phase II SERENITY trial in patients with Crohns disease and from a phase II trial for ulcerative colitis. Both trials showed that patients treated with mirikizumab achieved significantly greater rates of clinical and endoscopic remission at 12 weeks compared to placebo. Lilly is currently conducting six clinical trials in phase II and phase III, for both Crohns disease and ulcerative colitis.

Gilead, in global collaboration with Galapagos NV, is studying filgotinib, a highly selective JAK1 inhibitor. Results from a phase II study, FITZROY, were published in The Lancet in December of 2017. The study examined the efficacy and safety of filgotinib for the treatment of active moderate-to-severe Crohn's disease. Data showed filgotinib induced clinical remission in significantly more patients compared with placebo and had an acceptable safety profile. There are currently seven active phase II and III trials underway, including MANTA, DIVERSITY, DIVERGENCE2 and SELECTION 1.

Immunic Therapeutics is developing IMU-838, an oral tablet formulation of a small molecule drug (vidofludimus calcium), which inhibits dihydroorotate dehydrogenase (DHODH). Immunic completed two phase I studies in 2017, which evaluated single or repeated once-daily doses of IMU-838 in healthy volunteers. Results supported the tolerability of repeated daily dosing of up to 50 mg of IMU-838. A phase II trial, CALDOSE 1, is underway for ulcerative colitis.

Incyteis evaluating itacitinib, an orally administered small molecule Janus kinase 1 (JAK1) inhibitor. A double-blind, dose-ranging, placebo-controlled phase II trial is currently recruiting patients with moderate to severe ulcerative colitis.

Landos Biopharma's lead program is BT-11, an orally active, locally acting small molecule therapeutic that binds to LANCL2. In preclinical studies, it was shown to exert potent anti-inflammatory effects and was safe and well-tolerated with no dose-limiting toxicities in a phase I study. A phase II trial began in August of 2019 in patients with mild to moderate ulcerative colitis and is underway in Europe and the U.S. A second phase II study is anticipated to begin shortly in patients with moderate to severe Crohns disease, also in Europe and the United States.

Reistone Biopharma is developing SHR-0302, an orally administered selective JAK1 inhibitor. Two trials are underway: a phase II trial evaluating SHR0302 compared to placebo in patients with moderate to severe active ulcerative colitis and a phase II trial evaluating SHR-0302 in patients with moderate to severe active Crohn's Disease.

Seres Therapeutics is advancing with SER-287 is an oral capsule developed using Seres proprietary microbiome therapeutics platform. It is biologically-sourced and contains a consortium of live and diverse bacterial spores. SER-287 was designed to reduce the triggers of immune activation rather than suppress the immune system. Results from a phase Ib trial in patients with ulcerative colitis showed SER-287 microbiome treatment resulted in a dose-dependent benefit in clinical remission rates, and an improvement in endoscopic scores. A phase II trial, ECO-RESET, is currently recruiting 200 adults, age 18-80, with active mild-to-moderate ulcerative colitis.

Sublimity Therapeutics has developed an oral formulation of cyclosporine, referred to as ST-0529, using Sublimitys proprietary SmPill delivery system. Unlike conventional oral or intravenous cyclosporine, SmPill technology enables precise delivery of cyclosporine directly into diseased tissue in the colon, thus minimizing systemic exposure and unwanted side effects. In a phase IIa study ST-0529 was safe, well-tolerated and showed a numerically higher difference in remission rates in patients with mild-to-moderate ulcerative colitis compared to placebo after only four weeks of treatment. A phase IIb study, AURORA (CYC-202), is currently recruiting 280 subjects with moderately to severely active ulcerative colitis.

Theravanceand Janssen Biotech are collaborating on the development of TD-1473, an orally administered and intestinally restricted pan-Janus kinase (JAK) inhibitor. Data from a phase Ib trial demonstrated that four weeks of TD-1473 treatment produced signals of clinical, histologic, and biomarker activity in patients with moderately-to-severely active ulcerative colitis. A phase II trial, DIONE, is evaluating TD-1473 in subjects with moderately-to-severely active Crohn's Disease with up to 42 weeks of treatment. A phase II/III trial, RHEA, is evaluating the efficacy and safety of induction and maintenance therapy with TD-1473 in subjects with moderately-to-severely active ulcerative colitis with up to 60 weeks of treatment.

Phase III

Arena Pharmaceuticalsis developing etrasimod, a next-generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator designed for optimized pharmacology and engagement of S1P receptor 1, 4 and 5, which may lead to an improved efficacy and safety profile. The phase II OASIS trial met primary and all secondary endpoints with statistical significance for patients with ulcerative colitis receiving 2 mg dose of etrasimod for 12 weeks. Based on these results, Arena initiated the global phase III ELEVATE UC program, which consists of two worldwide clinical trials and an open-label extension study. In addition, planning is underway for a phase II/III trial in patients with Crohns disease.

Celgene's ozanimod targets the sphingosine-1-phosphate (S1P)-1 and -5 receptors. Results from phase II trials were reported in October of 2017. In the phase II STEPSTONE open-label study, ozanimod demonstrated meaningful clinical and endoscopic improvements in patients with moderately to severely active Crohn's disease at week 12. In the phase II TOUCHSTONE open-label extension study, ozanimod continued to demonstrate clinically meaningful results in moderately to severely active ulcerative colitis across multiple measures of disease activity through week 92. Celgene currently has nine active studies underway for both forms of IBD.

EA Pharma, a joint venture between Eisai Groups gastrointestinal disease business and Ajinomoto Group, is evaluating AJM300 (carotegrast methyl) an orally-active small molecule that antagonizes the 4 integrin receptor. A phase III trial was initiated in June of 2018 to evaluate AJM300 in patients with active ulcerative colitis.

RedHill Biopharma is evaluating RHB-104, a formulation of the generic antibiotics clarithromycin, rifabutin and clofazimine that is designed to treat Crohns disease by wiping out Mycobacterium avium paratuberculosis (MAP) infection.Some studies have linked infection with the bacterium to Crohns disease. In July of 2018, positive results were reported from the MAP US study, which evaluated RHB-104 for Crohns disease. The primary endpoint was successfully achieved, with superior remission rate at week 26 in patients treated with RHB-104 versus placebo.

Shire, a Takedacompany, has moved into phase III development with ontamalimab (SHP 647), a fully human IgG2 monoclonal antibody that targets mucosal addressin cell adhesion molecule (MADCAM1). Shire licensed the drug from Pfizer in 2016. Results from a phase II trial in patients with ulcerative colitis were published in the journal The Lancet in 2017 and demonstrated the treatment was safe and well-tolerated in this patient population, and better than placebo for induction of remission. Seven phase III trials are currently recruiting patients with both ulcerative colitis and Crohns disease.

Preclinical Candidates

The following is a sampling of companies that are preparing to develop and investigate drugs and other therapeutics in the preclinical laboratory setting. Data gathered from these preclinical trials will be used to determine whether the drug/therapy will move forward with clinical testing in humans.

AntaraLife Science's lead human health product is referred to as GaRP (Gastrointestinal ReProgramming). The GaRP product is a microbiome-targeted multi-component dietary supplement that has been designed to address the primary underlying factors associated with IBD and IBS. It is being positioned as an adjunct to existing therapies and not to replace existing prescription medications. Antara has completed the preclinical program, which provided strong scientific evidence that GaRP can combat the underlying causes of chronic bowel conditions, including inflammation and dysbiosis of the microbiome. Antara anticipates submitting regulator applications to move into clinical trials by the end of 2019.

Prometheus Bioscienceshas partnered with Takeda to discover, develop, and commercialize targeted therapies for inflammatory bowel disease. The collaboration combines the proprietary bioinformatics discovery platform and companion diagnostic tools developed by Prometheus Biosciences with Takeda's expertise in gastroenterology and drug development, in order to discover and advance up to three targeted IBD therapeutics and companion diagnostics.

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Inflammatory Bowel Disease Insight Report: Current Therapies, Drug Pipeline and Outlook - BioSpace



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