Gelesis200 Positive Safety Results

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PureTech Health PLC

03 May 2016

 

3 May 2016

PureTech Health plc

PureTech's Gelesis Announces Positive Safety Data from First-In-Human Study of Second Product Candidate, Gelesis200

PureTech Health plc ("PureTech", LSE: PRTC), a cross-disciplinary healthcare company tackling fundamental healthcare needs, is pleased to note that Gelesis, a PureTech business focused on the development of first-in-class products to safely induce weight loss and improve glycaemic control, today announced positive results from a first-in-human study of Gelesis200, its next-generation product designed for patients with type 2 diabetes. Gelesis200 is a novel oral capsulated device that seeks to induce weight loss and improve glycaemic control in patients with type 2 diabetes.

Eric Elenko, Executive Vice President of Science and Technology at PureTech, said: "We are pleased to note today's announcement that Gelesis' second product candidate, Gelesis200, has demonstrated positive safety and tolerability in its first-in-human study. Gelesis will now be able to assess Gelesis200 in a three-month proof-of-concept study, with the goal of ultimately offering a novel weight management and glycaemic control product for patients with type 2 diabetes."

The full text of the announcement from Gelesis is as follows:

Gelesis Announces Positive Safety Data from First-In-Human Study of Second Product Candidate, Gelesis200

Novel product for weight loss and glycaemic control in patients with type 2 diabetes proven safe and well-tolerated

BOSTON, Massachusetts, May 3, 2016 -- Gelesis, a biotechnology company focused on developing first-in-class products to safely induce weight loss and improve glycaemic control, today announced positive results from a first-in-human study of Gelesis200, its next-generation product designed for patients with type 2 diabetes. Gelesis200 is a novel oral capsulated device that seeks to induce weight loss and improve glycaemic control in patients with type 2 diabetes.

Results from the study showed Gelesis200 was generally well-tolerated. No serious adverse events (AEs) were reported, and the total number of AEs reported in the active treatment arms was comparable to the total number of AEs reported in the placebo arms.

"We are pleased with the safety and tolerability Gelesis200 demonstrated in this first-in-human study," said Hassan Heshmati, M.D., Chief Medical Officer of Gelesis. "Our next step will be to assess Gelesis200 in a three-month proof-of-concept study - expected to read out in the first half of 2017 - with the goal of ultimately offering a novel weight management and glycaemic control product for patients with type 2 diabetes."

The primary objective of this single-centre, randomised, double-blind, placebo-controlled, two-cohort, four-arm, crossover study was to evaluate the safety and tolerability of Gelesis200 following two or three administrations of 2.10 g in a single day - before breakfast and lunch or before breakfast, lunch and dinner - in adults who are overweight or have obesity but are otherwise considered healthy. The study was conducted in 24 male subjects with body mass indexes ranging from 28 to 33.

The data also indicated that administering Gelesis200 three times in a single day did not result in more AEs than administering it two times in a single day. Further, the timing of administration of Gelesis200 (10 minutes versus 30 minutes before a meal) did not affect the number of AEs.

The majority of AEs reported in the active treatment arms were mild, the most common of which were gastrointestinal-related and headache.

About Gelesis200

Gelesis200 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 glycaemic control in patients with type 2 diabetes. The hydrogel particles are synthesised through Gelesis' multi-step, proprietary process using starting materials that are considered Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration and commonly used in the food industry.

Gelesis200 capsules are taken with water prior to a meal, after which the hydrogel particles are released from the capsules in the stomach and rapidly absorb water, hydrating to approximately 85 times their original size to generate a feeling of fullness. Gelesis200's high elastic response and accelerated absorption mechanism makes it a prime candidate for potentially achieving glycaemic control in people with type 2 diabetes through multiple mechanisms of action through the GI. Once in the large intestine, the particles release most of the water, which is reabsorbed by the body. The microscopic degraded particles are then eliminated by the body in the same manner as food.

About Gelesis

Gelesis  is focused on the development of novel therapies to induce weight loss and improve glycaemic 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 optimised to induce weight loss and improve glycaemic control in patients with type 2 diabetes.

The Gelesis executive and advisory teams comprise 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, who also holds equity in Gelesis; 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.

Gelesis investors include Cormorant Asset Management, PureTech Health PLC (LSE: PRTC), Invesco Asset Management, the Pritzker/Vlock Family Office, and other prominent biotech and finance investors.

About PureTech Health

PureTech Health (PureTech Health plc, PRTC.L) is a cross-disciplinary healthcare company developing innovative products that could improve the lives of billions of patients. PureTech is focused on areas of growing scientific and technical insights that it believes are at an important inflection point, including the central nervous, gastro-intestinal and immune systems, and the interactions and signalling between them. PureTech has a pipeline of more than 30 programmes and has approximately 20 clinical studies across its pipeline, targeting multi-billion dollar market opportunities. PureTech's advanced programmes include five with human proof-of-concept and multiple with pivotal or registration study readouts in the next two years. PureTech's leading team and board, along with an advisory network of more than 60 expert founder-scientists and advisors across multiple disciplines, gives PureTech access to potentially ground-breaking science and technological innovation. With healthcare undergoing major transformation, PureTech believes it is well positioned to develop and launch medicines for the 21st century. For more information, visit http://www.puretechhealth.com and connect with us on Twitter.

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.

Enquiries

PureTech Allison Mead, Associate Director, Communications and Investor Relations	[phone]
FTI Consulting (Communications adviser to PureTech) Ben Atwell Matthew Cole	[phone]

 

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