Gelesis Announces First U.S. Patient Enrolled in Pivotal Gelesis100 Weight-Loss Study

BOSTON–(BUSINESS WIRE)–Gelesis,
a biotechnology company focused on the development of first-in-class
products to safely induce weight loss and improve glycemic 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 glycemic control. In a three-month proof-of-concept study,
Gelesis100 demonstrated statistically significant weight loss and
improvement of glycemic 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 glycemic 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 randomized, 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 glycemic control
parameters.
“There is a great need for new, safe therapeutic options that
facilitate both weight loss and glycemic 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 synthesized 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
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 Gelesis
Gelesis
is focused on the development of novel therapies designed 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 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.