First US Patient Enrolled in Gelesis100 Study
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.