Study Receives NSR designation from the FDA, allowing Company to expand to U.S. sites
BOSTON, Massachusetts, July 27, 2015: Gelesis, a clinical stage biotechnology company focused on the development of first-in-class products to induce weight loss and improve glycemic control, today announced plans to expand its ongoing GLOW (Gelesis Loss Of Weight) study to serve as a U.S. pivotal trial. Gelesis received positive confirmation from the U.S. Food and Drug Administration (FDA) that GLOW is a nonsignificant risk (NSR) device study, allowing the Company to expand the study to multiple U.S. sites.
“Expanding the GLOW study to a pivotal trial in the U.S. accelerates the development timeline for Gelesis100 and brings us one step closer to potentially launching a novel weight-loss therapy for overweight and obese patients,” said Hassan Heshmati, Chief Medical Officer of Gelesis. “We expect to begin enrolling patients in U.S. sites in the first quarter of 2016 and anticipate filing for FDA approval in the first half of 2017.”
The FDA’s NSR designation allows Gelesis to proceed with the study in the U.S. without submitting and obtaining approval of an investigational device exemption (IDE) application because Gelesis100 does not present a potential for serious risk to the health, safety, or welfare of a subject. NSR devices are those 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.
The GLOW study is a randomized, double-blind, placebo-controlled, parallel-group study designed to assess the effect of repeated administration of Gelesis100 over six months on body weight and glycemic control parameters in overweight and obese subjects, including those with prediabetes and type 2 diabetes. The primary endpoints for the study are placebo-adjusted change in total body weight from baseline to end of treatment, and percent of patients with at least five percent weight loss. The secondary endpoints include changes in key glycemic control parameters. The GLOW study was initiated in November 2014 and is currently being conducted in nine sites across four European countries. The expansion of the study will result in a study population of at least 336 patients (currently 168 patients) across the U.S. and Europe. Contingent upon successful completion of the GLOW study, this expansion should allow the Company to announce topline data and file for FDA approval in the first half of 2017, as opposed to the previously planned submission in the first half of 2018.
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 synthesized through Gelesis’ multi-step, proprietary process using starting 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 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, inducing satiety 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. Gelesis has completed its three-month proof-of-concept study, a 128-patient, randomized, double-blind, placebo-controlled, parallel-group study for Gelesis100 that demonstrated statistically significant weight loss and improvement of glycemic control parameters in overweight and obese patients, including prediabetics.
Gelesis is a clinical stage biotechnology company focused on the development of novel products to induce weight loss and improve glycemic control in overweight and obese patients, including those with prediabetes and diabetes. Gelesis 100, one of the company’s product candidates, is currently being evaluated in the six-month GLOW study. Gelesis is also developing Gelesis200, created from the same proprietary hydrogel technology platform as Gelesis100, as a product optimized to improve glycemic control in prediabetics and type 2 diabetics, who may or may not require weight loss. The Gelesis executive and advisory team includes leading experts in obesity and its related comorbidities, clinical research and development, and advanced biomaterials. Gelesis investors include PureTech Health PLC (LSE: PRTC), Invesco Perpetual, the Pritzker Family Office and prominent individual biotech and finance investors.