Gelesis Announces Last Patient Out in the Pivotal Gelesis100 Weight-Loss Study
July 12 2017 - 2:00AM
Business Wire
Company also expands to Europe its ongoing
study of second product candidate, Gelesis200, for weight loss and
glycemic control in people with prediabetes or type 2 diabetes
Gelesis, Inc., a biotechnology company developing a novel
category of therapies to safely induce weight loss, improve
glycemic control, and treat other chronic diseases related to the
gastrointestinal (GI) pathway, is pleased to report today that the
last patient has completed treatment in the pivotal GLOW (Gelesis
Loss Of Weight) Study. The GLOW study was designed to assess the
long-term efficacy and safety of lead product candidate Gelesis100
over a six-month period across a broad patient population. The
company has also enrolled its first European patient in the ongoing
LIGHT-UP study with its second product candidate, Gelesis200, for
weight loss and glycemic control. The study will enroll individuals
who are overweight or have obesity and also have prediabetes or
metformin-treated type 2 diabetes at more than 30 sites across the
United States, Canada, and Europe.
“We’re pleased to have reached these two milestones for Gelesis
as we continue to progress our platform technology and expand our
pipeline,” said Hassan Heshmati MD, Chief Medical Officer of
Gelesis. “We’re also continuing to establish a body of data around
our platform technology, as we explore additional GI-related
conditions such as nonalcoholic fatty liver disease (NAFLD),
nonalcoholic steatohepatitis (NASH), and inflammatory bowel disease
(IBD).”
Further investigation of the Gelesis mechanism has led to an
international collaboration with leading obesity and nutrition
experts and new insights about how people with prediabetes respond
to different types of diets, published in the American Journal of
Clinical Nutrition. “We are learning a remarkable amount about the
potential positive impact on local inflammation and glycemic
parameters through our unique hydrogel system that is at the
forefront of mechanobiology,” added Elaine Chiquette, Pharm.D., EVP
Head of Science, Gelesis. “This emerging field at the interface of
biology and engineering focuses on how cells sense and respond to
mechanical stimuli and is helping us to unlock insights into the
gut-brain-inflammation axis.”
About Gelesis100 and Gelesis200Gelesis100 is a
pivotal-stage product candidate for weight loss and glycemic
control, which has demonstrated statistically significant weight
loss, reduced hunger, increased satiety and strong safety in
previous clinical studies. Gelesis200 is a second product candidate
that has been engineered for rapid hydration with significantly
higher elasticity to enhance glycemic control and weight loss for
patients who have pre-diabetes or type 2 diabetes. A
proof-of-concept clinical study with Gelesis200 (LIGHT-UP) has been
initiated for weight loss and glycemic control in people with
prediabetes or type 2 diabetes. The results from this study are
expected mid-2018.
Both Gelesis100 and Gelesis200 are orally – administered
capsules containing small hydrogel particles made by cross-linking
two naturally occurring food ingredients to generate novel
compositions that are expected to be safe and well tolerated.
Gelesis product candidates are designed to employ multiple
mechanisms of action that leverage mechanotransduction along the
gastrointestinal (GI) tract to induce weight loss and improve
glycemic control. The hydrogel particles swell and shrink in
different parts of the GI system, mix homogeneously with food,
travel through the GI tract, and – once in the large intestines –
release most of the water, which is reabsorbed by the body. The
small hydrogel particles are then safely eliminated by the body in
the same manner as food.
To our knowledge, Gelesis’ novel hydrogels are the only super
absorbents made from materials which are considered Generally
Recognized As Safe (GRAS) by the U.S. Food and Drug Administration
(FDA) and commonly used in foods. Gelesis also received positive
confirmation from the FDA that GLOW is a nonsignificant risk (NSR)
device study. Gelesis holds 11 families of patents, several of
which have already been allowed or issued in major markets. Most
recently, Gelesis received a Notice of Allowance from Japan Patent
Office (JPO) on Patent No. 2014-514632 covering composition of
matter for Gelesis100.
About GelesisGelesis is developing a novel hydrogel
platform to treat obesity and other chronic diseases related to the
gastrointestinal (GI) pathway. Gelesis’ proprietary approach acts
mechanically in the GI system to potentially alter the course of
chronic diseases safely and effectively. Gelesis is currently
evaluating its lead product candidate, Gelesis100, in a pivotal
trial for weight loss, which is expected to read out in Q3 2017.
Additionally, Gelesis recently initiated a proof-of-concept study
for its second candidate, Gelesis200, which is optimized for weight
loss and glycemic control in patients with type 2 diabetes and
pre-diabetes. New hydrogel compositions based on the Gelesis
platform are also being explored in preclinical and pilot studies
in other GI-related conditions such as nonalcoholic fatty liver
disease (NAFLD), nonalcoholic steatohepatitis (NASH), and
inflammatory bowel disease (IBD).
The Gelesis executive and advisory team includes some of the
world’s leading experts in obesity research and clinical
development, innovators in material science, and entrepreneurs.
Gelesis was co-founded by PureTech Health (PRTC.L), an
advanced, clinical-stage biopharmaceutical company (www.puretechhealth.com).
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170711006688/en/
Gelesis, Inc.Allison Mead, +1
617-651-3156amead@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