BOSTON–(BUSINESS WIRE)–Gelesis, a biotechnology company developing first-in-class
mechanotherapeutics to treat obesity and other chronic diseases related
to the gastrointestinal (GI) tract, today announced the Company will
deliver three poster presentations at ENDO, the Endocrine Society Annual
Meeting, held in New Orleans from March 23-26.
Two of the presentations will share expanded clinical data from the
pivotal study of Gelesis100, an oral, non-systemic approach to weight
loss. A third will highlight preclinical data suggesting a different
product candidate derived from Gelesis’ proprietary hydrogel platform
can restore gut barrier function in mice with severe gut wall injury.
“We are pleased to share expanded clinical data which seeks to address
crucial public health issues associated with overweight and obesity. We
are also excited to present our latest research on leveraging our
hydrogel technology in chronic diseases of the GI system,” said Harry L.
Leider, M.D., MBA, FACPE, Chief Medical Officer of Gelesis. “We look
forward to discussing our findings with the scientific community.”
Details of the presentations are as follows:
Poster Title: Gelesis100 Reduces Insulin Resistance in Patients
Who Are Overweight or Have Obesity with High Insulin Resistance: Results
of the GLOW Study
Poster Session: P50. Obesity Mechanisms
and Treatments Potpourri
Date and Time: March 25, 2019,
(1:00 – 3:00 PM)
Poster Location: Poster Board #MON-112,
ENDO Expo Hall, Ernest N. Morial Convention Center
Poster Title: Elevated Fasting Plasma Glucose Predicts Higher
Odds for Becoming a Super-Responder with Gelesis100 in the GLOW Pivotal
Weight-Loss Study
Poster Session: P05. Obesity Comorbidities
and Therapies
Date and Time: Saturday, March 23, 2019 (1:00
– 3:00 PM)
Poster Location: Poster Board # SAT-LB023, ENDO
Expo Hall, Ernest N. Morial Convention Center
Poster Title: Gelesis Novel, Non-Systemic, Superabsorbent
Hydrogel Improves Intestinal Barrier Function in Intestinal Injury
Pre-Clinical Model
Poster Session: P50. Obesity Mechanisms
and Treatments Potpourri
Date and Time: Monday, March 25,
2019 (1:00 – 3:00 PM)
Poster Location: Poster Board #
MON-LB022, ENDO Expo Hall, Ernest N. Morial Convention Center
About Gelesis 100
Gelesis100 is a non-systemic,
superabsorbent hydrogel in development for the potential treatment of
overweight or obesity. It is made from two naturally derived building
blocks, modified cellulose cross-linked with citric acid, that create a
three-dimensional matrix. Orally administered in capsules with water
before a meal, Gelesis100 particles rapidly absorb water in the stomach
and homogenously mix with ingested foods. When hydrated, Gelesis100
occupies about one-fourth of the average stomach volume. Rather than
forming one large mass, it creates thousands of small individual gel
pieces with the elasticity (firmness) of solid ingested foods (e.g.,
vegetables) without caloric value. Gelesis100 maintains its
three-dimensional structure and mechanical properties during transit
through the small intestine. Once it arrives in the large intestine, the
hydrogel is partially broken down by enzymes and loses its
three-dimensional structure along with most of its absorption capacity.
The released water is reabsorbed in the large intestine, and the
remaining cellulosic material is expelled in the feces. Gelesis100 is
considered a medical device because it achieves its primary intended
purpose through mechanical modes of action consistent with
mechanobiology constructs. Gelesis100 received a Non-Significant Risk
(NSR) designation by the FDA.
This investigational product has been studied in more than 450 patients
(excluding patients treated by placebo) across five clinical studies
throughout the United States, Canada, and Europe. Other than an increase
in overall gastrointestinal adverse events (AEs), most of which were
assessed as mild, there was no difference in the incidence and severity
of AEs between the Gelesis100 and placebo groups. In both treatment
groups, most AEs were mild or moderate in intensity. No serious adverse
events were observed in the Gelesis100 group. Gelesis100 is pending De
Novo clearance and is not available for sale in the United States.
About Gelesis
Gelesis is developing a novel mechanobiology
platform technology to treat obesity and other chronic diseases related
to the GI pathway. Gelesis’ proprietary approach is designed to act
mechanically in the GI pathway to potentially alter the course of
chronic diseases. In September 2017, Gelesis completed a pivotal trial
for weight loss evaluating its lead investigational product candidate
Gelesis100. Additionally, Gelesis is conducting 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 prediabetes.
Novel hydrogel mechanotherapeutics based on the Gelesis platform
technology are also being advanced through a pipeline with preclinical
studies in other GI-related conditions such as non-alcoholic fatty liver
disease (NAFLD), non-alcoholic steatohepatitis (NASH), and inflammatory
bowel disease (IBD).
The Gelesis executive and advisory team includes some of the world’s
leading experts in obesity, chronic disease research, and materials
science. Gelesis was co-founded by PureTech Health (LSE: PRTC), an
advanced, clinical-stage biopharmaceutical company. For more
information, visit www.gelesis.com or
connect with us on Twitter @GelesisInc.
Contacts
Investors
Kathryn McNeil
+1 347 204 4226
kmcneil@gelesis.com
U.S. media
Tom Donovan
+1 857 559 3397
tom@tenbridgecommunications.com