First US Patient Enrolled in Gelesis100 Study
26 April 2016
PureTech Health plc
PureTech's Gelesis Announces First U.S. Patient Enrolled in Pivotal Gelesis100 Weight-Loss Study and Allowance of Key Patent
U.S. enrolment further advances global pivotal study with 125 European patients having completed study to date
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 the first patient enrolled from the United States (U.S.) in its pivotal GLOW (Gelesis Loss Of Weight) study. Gelesis also announced the allowance of a composition of matter patent from the U.S. Patent and Trademark Office (USPTO) for Gelesis' technology.
Eric Elenko, Executive Vice President of Science and Technology at PureTech said: "We are excited to advance the global study of our proprietary technology, which we hope will help address the growing obesity epidemic. We have engaged many of the top U.S. obesity experts as investigators in this study to examine the full potential of Gelesis100 in adults who are overweight or have obesity, including those with prediabetes and type 2 diabetes, and we look forward to potentially bringing a safe and effective treatment option to those who will benefit from it most."
The full text of the announcement from Gelesis is as follows:
Gelesis Announces First U.S. Patient Enrolled in Pivotal Gelesis100 Weight-Loss Study
Company granted U.S. composition of matter patent for Gelesis' technology
BOSTON, Massachusetts, April 26, 2016 - Gelesis, a biotechnology company focused on the development of first-in-class products to safely induce weight loss and improve glycaemic control, today announced the first patient enrolled from the United States (U.S.) in its pivotal GLOW (Gelesis Loss Of Weight) study. GLOW will assess the long-term safety and efficacy of Gelesis100, a novel oral capsulated device designed to achieve weight loss in adults who are overweight or have obesity, including those with prediabetes and type 2 diabetes. GLOW was initiated in November 2014 and has been ongoing at nine clinical trial sites across four European countries, where 125 patients have completed treatment.
The company also announced the allowance of a composition of matter patent from the U.S. Patent and Trademark Office (USPTO) for Gelesis' technology through 2032.
The Gelesis100 capsule contains small hydrogel particles that, when taken with water ahead of a meal, is designed to employ multiple mechanisms of action along the gastrointestinal (GI) tract to induce weight loss and improve glycaemic control. In a three-month proof-of-concept study, Gelesis100 demonstrated statistically significant weight loss and improvement of glycaemic control in adults who are overweight or have obesity, especially in those with prediabetes. GLOW will study the impact of Gelesis100 in achieving weight loss and glycaemic control over a six-month time period and in a broader patient population, including those who have type 2 diabetes, across 32 sites in the U.S., Canada and Europe.
GLOW is a randomised, double-blind, placebo-controlled, parallel-group study of 460 adults who are overweight or have obesity (Body Mass Index: 27-40) between the ages of 22 to 65 years, including those with prediabetes and type 2 diabetes. The study's primary endpoints are placebo-adjusted change in total body weight from baseline to end of treatment, and percent of individuals with at least five percent weight loss. The secondary endpoints include changes in key glycaemic control parameters.
"There is a great need for new, safe therapeutic options that facilitate both weight loss and glycaemic control, especially in people with prediabetes," said Gelesis Scientific Advisory Board member Caroline Apovian, M.D., Professor of Medicine and Pediatrics at Boston University School of Medicine. "We are excited to study the Gelesis product in the U.S. with some of the top clinicians in this field."
Gelesis received positive confirmation from the U.S. Food and Drug Administration (FDA) in July 2015 that GLOW received a Non-Significant Risk (NSR) medical device study designation, which allowed the Company to expand the study to the U.S. The FDA's NSR designation applies to devices that are generally considered to be low risk based on their intended use in the study. Examples of NSR devices include daily wear contact lenses, dental filling materials and jaundice monitors for infants.
"Enrolling our first patient in the U.S. is an important milestone as we advance this novel therapeutic as a potentially effective, non-invasive weight-loss treatment for adults who are overweight or have obesity," said Hassan Heshmati, M.D., Chief Medical Officer of Gelesis. "More than two-thirds of U.S. adults are overweight or obese, so there is a critical need for new approaches that can help these individuals achieve and maintain a healthy weight."
Gelesis recently received a Notice of Allowance from the USPTO for a patent application covering composition of matter. The issued patent will have a term extending to 2032. Gelesis already owns two additional patent families with granted or allowed patents in the US, Europe, Canada, Australia, Japan, Russia, Mexico, China and Hong Kong. Several other patent families are in different stages of prosecution.
About Gelesis100
Gelesis100 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 are synthesised through Gelesis' multi-step, proprietary process using starting materials which are considered Generally Recognized As Safe (GRAS) by the FDA and commonly used in the food industry.
Gelesis100 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 100 times their original size. The hydrogel particles mix homogeneously with food and travel through the GI tract, potentially inducing satiety and improving glycaemic 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 Gelesis
Gelesis is focused on the development of novel therapies designed 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 prediabetes and type 2 diabetes.
The Gelesis executive and advisory team includes 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 Priztker/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 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.
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