Gelesis, focused on developing first-in-class products to safely induce weight loss and improve glycemic control, today presented new data for its second product candidate, Gelesis200, at ObesityWeek 2016, the annual combined congress of the American Society for Metabolic and Bariatric Surgery and The Obesity Society. Data from this first-in-human study demonstrated that administration 10 minutes prior to a meal increased fullness throughout the entire day (P = 0.012).
The purpose of the analysis was to determine the effect of Gelesis200 on subject-reported appetite scores following two or three administrations in a single day. In addition to increasing feelings of fullness, administration of Gelesis200 10 minutes prior to breakfast, lunch, and dinner resulted in greater satiety immediately preceding dinner (P = 0.017) and at 150 minutes and 180 minutes after dinner (P = 0.032 and P = 0.031, respectively). Gelesis200 was well-tolerated and its safety profile was similar to placebo in this study.
“Gelesis200 is the second product comprised from our proprietary hydrogel platform, and it has been designed specifically for weight management as well as glycaemic control,” said Hassan Heshmati MD, Gelesis Chief Medical Officer. “Together with the safety and tolerability results announced earlier this year from the same study, these new data support the advancement of Gelesis200.”
Gelesis also presented pharmacokinetic data for its lead, pivotal-stage product, Gelesis100, which showed that administration of Gelesis100 with metformin hydrochloride 850 mg (immediate release tablet) was safe, well-tolerated, and affected metformin pharmacokinetics similarly to food alone. Since metformin is typically administered with food, these results demonstrated that Gelesis100 could potentially be used safely for weight management in patients with type 2 diabetes who take metformin.
Gelesis100 is a pivotal stage treatment for weight loss and glycemic control, which has demonstrated statistically significant weight loss and safety in its previous studies. The treatment is an orally administered capsule containing small hydrogel particles designed to employ multiple mechanisms of action along the gastrointestinal (GI) tract to induce weight loss and improve glycemic control. The hydrogel particles, which form a new chemical entity, are synthesized through Gelesis’ multi-step, proprietary process using starting materials which are considered Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration (FDA) and commonly used in the food industry.
Gelesis100 capsules are taken with water prior to a meal, after which the thousands of small hydrogel particles in each capsule are released from the capsules in the stomach and rapidly absorb water, hydrating to approximately 100 times their original size. The hydrogel particles mix homogeneously with food and travel through the GI tract, inducing weight loss and improving glycemic control. Once in the large intestine, the particles release most of the water, which is reabsorbed by the body. The microscopic degraded particles are then safely eliminated by the body in the same manner as food.
Gelesis200 leverages the proprietary hydrogel technology of Gelesis100 but has been engineered with different physical properties. It takes up slightly less volume than Gelesis100; however, it has more rapid hydration and greater elasticity and viscosity. These characteristics are designed to enhance glycemic control and weight loss for patients who have prediabetes or type 2 diabetes. Like Gelesis100, Gelesis200 is an orally administered capsule containing small hydrogel particles synthesized through Gelesis’ multi-step, proprietary process using starting materials that are considered GRAS by the FDA and commonly used in the food industry.
Gelesis is focused on the development of novel therapies to induce weight loss and improve glycemic control in people who are overweight or have obesity, including those with prediabetes and type 2 diabetes. Gelesis100, one of the company’s product candidates and a first-in-class therapeutic, is currently being evaluated in a six-month pivotal study. Gelesis is also developing Gelesis200, created from the same proprietary technology platform as Gelesis100, as a product optimized to induce weight loss and improve glycemic control in patients with type 2 diabetes.
The Gelesis advisory team is comprised of leading experts in obesity and its related comorbidities, clinical research and development and advanced biomaterials, including Caroline Apovian, M.D., Professor of Medicine and Pediatrics at Boston University School of Medicine; Louis J. Aronne, M.D., FACP, Director of the Comprehensive Weight Control Program at Weill Cornell Medicine; Arne Astrup, M.D., Head of Department of Nutrition, Exercise and Sports at University of Copenhagen; Ken Fujioka, M.D., Director of the Nutrition and Metabolic Research Center and the Center for Weight Management at the Scripps Clinic; Allan Geliebter, Ph.D., Senior Attending Psychologist, St. Luke's-Roosevelt Hospital; James Hill, Ph.D., Professor of Medicine and Pediatrics, University of Colorado; Lee M. Kaplan, M.D., Ph.D., Director of the Obesity, Metabolism and Nutrition Institute at Massachusetts General Hospital; Bennett Shapiro, M.D., Co-founder and Non-Executive Director at PureTech and former Executive Vice President of Research for Merck; and Angelo Tremblay, Ph.D., professor, Department of Kinesiology at Laval University. Some of these advisors hold equity in Gelesis.
Gelesis shareholders include Cormorant Asset Management, PureTech Health PLC (LSE: PRTC), Invesco Asset Management, the Pritzker/Vlock Family Office, and other prominent biotech and finance leaders.
Forward Looking Statement
This press release contains statements that are or may be forward-looking statements, including statements that relate to the company's future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
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Last updated on: 04/11/2016
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