- Gelesis100 2.25 g demonstrated significant weight loss in a double-blind, placebo-controlled, parallel-group 12-week study of overweight and obese subjects, including prediabetics
BOSTON, June 23, 2014 /PRNewswire/ -- Gelesis Inc., a company focused on developing treatments for overweight and obese subjects, including prediabetics, presented today the results of a proof of concept study with its lead product, Gelesis100. In the 12-week study, 2.25 g of Gelesis100 taken twice a day showed statistically significant weight loss in overweight and obese subjects, with particularly dramatic weight loss in prediabetics. The results of the First Loss Of Weight (FLOW) study were presented at the joint meeting of the International Congress of Endocrinology and The Endocrine Society: ICE/ENDO 2014 in Chicago. The Gelesis FLOW study was selected as being especially newsworthy by the conference organizers and will be discussed at an ICE/ENDO news conference on Obesity at 11:45-12:35 a.m. (ET) today.
"Gelesis100 represents an entirely new approach to treating obesity. These results are exciting and show that Gelesis100 has the potential to provide a truly novel alternative for weight loss that does not involve surgery, injections, or systemically absorbed drugs," said lead study investigator Professor Arne Astrup, MD, a leading obesity expert and Head of The Department of Human Nutrition, Exercise and Sports at the University of Copenhagen, Denmark.
FLOW was a multicenter, double-blind, placebo-controlled, parallel-group, 12-week trial, designed to explore dose-ranging and test efficacy, safety, and tolerability. The effect on body weight of chronic oral administration of Gelesis100 was assessed in 128 non-diabetic, overweight and obese subjects randomized to two Gelesis100 arms (2.25 g twice daily, n = 43 and 3.75 g twice daily, n = 42) and a placebo arm (n = 43). Subjects swallowed capsules containing Gelesis100 or placebo with 500 mL of water (two glasses) before lunch and dinner and received counseling to reduce their diet by ~600 kcal/day below their daily requirements. The placebo capsules contained microcrystalline cellulose, a non-digestible fiber and bulking agent with low water absorption capacity and potential weight-loss properties.
One hundred twenty-five subjects had at least one post-baseline body weight assessment (intention-to-treat "ITT" population). The ITT population (40 males, 85 females) had a mean age ± standard deviation (SD) of 44 ± 12 years and a mean body mass index ± SD of 31.7 ± 2.4. In the ITT population, the mean ± SD body weight percent changes from baseline to the end of treatment were -6.1 ± 5.1% (P=0.026), -4.5 ± 4.5%, and -4.1 ± 4.4%, with Gelesis100 2.25 g, Gelesis100 3.75 g, and placebo, respectively. Subjects receiving the 2.25 g of Gelesis100 who had elevated fasting blood glucose before treatment (> median of 93 mg/dL) had greater weight loss, losing 8.2 ± 5.3% (3.8% placebo adjusted; P = 0.006) of their body weight. The greatest weight loss occurred in prediabetic subjects whose starting fasting blood glucose level was 100 to 125.9 mg/dL. They lost an average of 10.9 ± 4.3% (5.3% placebo adjusted; P = 0.019) of their body weight in three months. There was a significant inverse correlation between fasting glucose at baseline and change in body weight in Gelesis100 2.25 g arm (r = -0.50; P < 0.001), contrasting with a lack of correlation in the placebo arm (r = -0.06; P = 0.708).
"Weight loss was particularly dramatic in subjects who had impaired levels of fasting blood glucose (prediabetic subjects)," said Hassan Heshmati, MD, Chief Medical Officer for Gelesis and a study co-investigator. "Given the significant efficacy and excellent safety profile observed in the FLOW study, Gelesis100 has the potential to fulfill the unmet need for a safe and effective weight loss therapy. This is especially important for prediabetic subjects who need to manage weight because they are at increased risk for diabetes," Heshmati said.
Conversion from obese status at baseline to overweight status at end of study was observed in 39% of subjects on Gelesis100 2.25 g, 24% of subjects on Gelesis100 3.75 g, and 17% of subjects on placebo. Conversion from overweight status at baseline to normal weight status at end of study was observed in 29% of subjects on Gelesis100 2.25 g, 8% of subjects on Gelesis100 3.75 g, and 0% of subjects on placebo. Conversion from prediabetes status at baseline to normal sugar status at end of study was observed in 56% of subjects on Gelesis100 2.25 g, 78% of subjects on Gelesis100 3.75 g, and 27% of subjects on placebo.
"Gelesis100 is a new class of therapy, an orally administered capsulated device, where each capsule contains thousands of tiny hydrogel particles that expand in the stomach and small intestine," said Gelesis' Founder and Chief Executive Officer, Yishai Zohar. "The product is designed to increase the volume and elasticity of the stomach and small intestine contents, delaying gastric emptying, and leading to longer post-meal satiety with subsequent weight loss. Gelesis100 will be regulated as a medical device if approved by the FDA, but is anticipated to be prescribed and administered like a drug," Zohar added.
"The Gelesis technology represents an important advance in material science," said Dr. Robert Langer, Institute Professor at MIT, and a leading expert in polymers and materials science, "It is the first and only superabsorbent hydrogel that I know of which is constructed from food ingredients and doesn't use potentially toxic organic solvents. By cross-linking two components together using a proprietary synthesis, Gelesis scientists created a three dimensional structure that is engineered to ideally function through the gastrointestinal tract to increase satiety and reduce hunger."
Lower tolerability leading to reduced compliance may explain the observed lower weight loss observed with the 3.75 g dose. The most common side effects were of gastrointestinal origin and included bloating, flatulence, abdominal pain, and diarrhea. They occurred less often at the 2.25 g dose which was the best tolerated active dose. The number of side effects reported by subjects on 2.25 g of Gelesis100 was even lower than the number in subjects on placebo. Dropout rates were 5%, 24%, and 21%, with Gelesis100 2.25 g, Gelesis100 3.75 g, and placebo, respectively. Of the 2 dropouts on 2.25 g, neither reported side effects while all of the 9 dropouts on 3.75 g reported side effects.
Obesity is a medical condition where accumulation of excess body fat can lead to serious and negative effects on health and life expectancy. The prevalence of obesity worldwide continues to grow, with approximately 100 million obese or morbidly obese individuals in the United States alone. Obesity increases the lifetime chances that an individual will have additional complications such as type 2 diabetes, heart disease, osteoarthritis, and certain types of cancer.
Gelesis100 (formerly "Attiva") is an oral capsulated device for weight loss. Each capsule contains thousands of particles of a proprietary, biocompatible superabsorbent hydrogel synthesized with starting materials that have been designated as GRAS (Generally Recognized as Safe). Gelesis100 capsules are taken orally prior to a meal and contain small particles that expand ~100 times when hydrated in the stomach and small intestine, triggering several important satiety and glycemic control mechanisms. Gelesis100 has several built in safety features: a) the volume it creates is limited by the amount of water consumed, b) the hydrated particles which are ~2 mm in size, cannot aggregate to form a larger mass and have similar elasticity (rigidity) to ingested food, and c) the particles partially degrade in the colon, releasing absorbed water. For more product features and details and to view an animation: http://www.gelesis.com/our-approach.php.
About Gelesis, Inc.
Gelesis is a clinical stage company developing a new category of therapy to safely treat overweight, obese, and diabetic subjects. The Gelesis executive and advisory team includes the world's top experts in obesity research and clinical development, entrepreneurs, and innovators in advanced materials. Gelesis has raised over $42M in equity and non-dilutive funding since its inception. Gelesis was co-founded by PureTech, a venture creation company tackling tomorrow's biggest healthcare challenges.
SOURCE Gelesis, Inc.