BOSTON--(BUSINESS WIRE)--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.
About Gelesis100
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.
About Gelesis200
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.
About Gelesis
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.
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