Administration of Gelesis200 Increases Fullness and Satiety in People who are Overweight or Have Obesity
November 04 2016 - 2:00AM
Business Wire
Data Presented At Annual ObesityWeek
Congress
Gelesis, focused on developing first-in-class products to safely
induce weight loss and improve glycemic control, today presented
new data for its second product candidate, Gelesis200, at
ObesityWeek 2016, the annual combined congress of the American
Society for Metabolic and Bariatric Surgery and The Obesity
Society. Data from this first-in-human study demonstrated that
administration 10 minutes prior to a meal increased fullness
throughout the entire day (P = 0.012).
The purpose of the analysis was to determine the effect of
Gelesis200 on subject-reported appetite scores following two or
three administrations in a single day. In addition to increasing
feelings of fullness, administration of Gelesis200 10 minutes prior
to breakfast, lunch, and dinner resulted in greater satiety
immediately preceding dinner (P = 0.017) and at 150 minutes and 180
minutes after dinner (P = 0.032 and P = 0.031, respectively).
Gelesis200 was well-tolerated and its safety profile was similar to
placebo in this study.
“Gelesis200 is the second product comprised from our proprietary
hydrogel platform, and it has been designed specifically for weight
management as well as glycaemic control,” said Hassan Heshmati MD,
Gelesis Chief Medical Officer. “Together with the safety and
tolerability results announced earlier this year from the same
study, these new data support the advancement of Gelesis200.”
Gelesis also presented pharmacokinetic data for its lead,
pivotal-stage product, Gelesis100, which showed that administration
of Gelesis100 with metformin hydrochloride 850 mg (immediate
release tablet) was safe, well-tolerated, and affected metformin
pharmacokinetics similarly to food alone. Since metformin is
typically administered with food, these results demonstrated that
Gelesis100 could potentially be used safely for weight management
in patients with type 2 diabetes who take metformin.
About Gelesis100Gelesis100 is a pivotal stage treatment
for weight loss and glycemic control, which has demonstrated
statistically significant weight loss and safety in its previous
studies. The treatment 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, which form a
new chemical entity, are synthesized through Gelesis’ multi-step,
proprietary process using starting materials which 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 thousands of small hydrogel particles in each capsule 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 weight loss 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 Gelesis200Gelesis200 leverages the proprietary
hydrogel technology of Gelesis100 but has been engineered with
different physical properties. It takes up slightly less volume
than Gelesis100; however, it has more rapid hydration and greater
elasticity and viscosity. These characteristics are designed to
enhance glycemic control and weight loss for patients who have
prediabetes or type 2 diabetes. Like Gelesis100, Gelesis200 is an
orally administered capsule containing small hydrogel particles
synthesized through Gelesis’ multi-step, proprietary process using
starting materials that are considered GRAS by the FDA and commonly
used in the food industry.
About GelesisGelesis is focused on the development of
novel therapies 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 type 2
diabetes.
The Gelesis advisory team is comprised of 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;
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. Some of these
advisors hold equity in Gelesis.
Gelesis shareholders include Cormorant Asset Management,
PureTech Health PLC (LSE: PRTC), Invesco Asset Management, the
Pritzker/Vlock Family Office, and other prominent biotech and
finance leaders.
Forward Looking StatementThis 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161104005123/en/
PureTechAllison Mead, +1 617-651-3156Director,
Communications and Investor Relationsamead@puretechhealth.com
Puretech Health (LSE:PRTC)
Historical Stock Chart
From Apr 2024 to May 2024
Puretech Health (LSE:PRTC)
Historical Stock Chart
From May 2023 to May 2024