TIDMPRTC
PureTech Health PLC
03 May 2016
3 May 2016
PureTech Health plc
PureTech's Gelesis Announces Positive Safety Data from
First-In-Human Study of Second Product Candidate, Gelesis200
PureTech Health plc ("PureTech", LSE: PRTC), a
cross-disciplinary healthcare company tackling fundamental
healthcare needs, is pleased to note that Gelesis, a PureTech
business focused on the development of first-in-class products to
safely induce weight loss and improve glycaemic control, today
announced positive results from a first-in-human study of
Gelesis200, its next-generation product designed for patients with
type 2 diabetes. Gelesis200 is a novel oral capsulated device that
seeks to induce weight loss and improve glycaemic control in
patients with type 2 diabetes.
Eric Elenko, Executive Vice President of Science and Technology
at PureTech, said: "We are pleased to note today's announcement
that Gelesis' second product candidate, Gelesis200, has
demonstrated positive safety and tolerability in its first-in-human
study. Gelesis will now be able to assess Gelesis200 in a
three-month proof-of-concept study, with the goal of ultimately
offering a novel weight management and glycaemic control product
for patients with type 2 diabetes."
The full text of the announcement from Gelesis is as
follows:
Gelesis Announces Positive Safety Data from First-In-Human Study
of Second Product Candidate, Gelesis200
Novel product for weight loss and glycaemic control in patients
with type 2 diabetes proven safe and well-tolerated
BOSTON, Massachusetts, May 3, 2016 -- Gelesis, a biotechnology
company focused on developing first-in-class products to safely
induce weight loss and improve glycaemic control, today announced
positive results from a first-in-human study of Gelesis200, its
next-generation product designed for patients with type 2 diabetes.
Gelesis200 is a novel oral capsulated device that seeks to induce
weight loss and improve glycaemic control in patients with type 2
diabetes.
Results from the study showed Gelesis200 was generally
well-tolerated. No serious adverse events (AEs) were reported, and
the total number of AEs reported in the active treatment arms was
comparable to the total number of AEs reported in the placebo
arms.
"We are pleased with the safety and tolerability Gelesis200
demonstrated in this first-in-human study," said Hassan Heshmati,
M.D., Chief Medical Officer of Gelesis. "Our next step will be to
assess Gelesis200 in a three-month proof-of-concept study -
expected to read out in the first half of 2017 - with the goal of
ultimately offering a novel weight management and glycaemic control
product for patients with type 2 diabetes."
The primary objective of this single-centre, randomised,
double-blind, placebo-controlled, two-cohort, four-arm, crossover
study was to evaluate the safety and tolerability of Gelesis200
following two or three administrations of 2.10 g in a single day -
before breakfast and lunch or before breakfast, lunch and dinner -
in adults who are overweight or have obesity but are otherwise
considered healthy. The study was conducted in 24 male subjects
with body mass indexes ranging from 28 to 33.
The data also indicated that administering Gelesis200 three
times in a single day did not result in more AEs than administering
it two times in a single day. Further, the timing of administration
of Gelesis200 (10 minutes versus 30 minutes before a meal) did not
affect the number of AEs.
The majority of AEs reported in the active treatment arms were
mild, the most common of which were gastrointestinal-related and
headache.
About Gelesis200
Gelesis200 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 glycaemic control in patients with type 2 diabetes. The
hydrogel particles are synthesised through Gelesis' multi-step,
proprietary process using starting materials that are considered
Generally Recognized as Safe (GRAS) by the U.S. Food and Drug
Administration and commonly used in the food industry.
Gelesis200 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 85
times their original size to generate a feeling of fullness.
Gelesis200's high elastic response and accelerated absorption
mechanism makes it a prime candidate for potentially achieving
glycaemic control in people with type 2 diabetes through multiple
mechanisms of action through the GI. Once in the large intestine,
the particles release most of the water, which is reabsorbed by the
body. The microscopic degraded particles are then eliminated by the
body in the same manner as food.
About Gelesis
Gelesis is focused on the development of novel therapies to
induce weight loss and improve glycaemic 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 optimised to induce weight loss and
improve glycaemic control in patients with type 2 diabetes.
The Gelesis executive and advisory teams comprise 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
Pritzker/Vlock Family Office, and other prominent biotech and
finance investors.
About PureTech Health
PureTech Health (PureTech Health plc, PRTC.L) is a
cross-disciplinary healthcare company developing innovative
products that could improve the lives of billions of patients.
PureTech is focused on areas of growing scientific and technical
insights that it believes are at an important inflection point,
including the central nervous, gastro-intestinal and immune
systems, and the interactions and signalling between them. PureTech
has a pipeline of more than 30 programmes and has approximately 20
clinical studies across its pipeline, targeting multi-billion
dollar market opportunities. PureTech's advanced programmes include
five with human proof-of-concept and multiple with pivotal or
registration study readouts in the next two years. PureTech's
leading team and board, along with an advisory network of more than
60 expert founder-scientists and advisors across multiple
disciplines, gives PureTech access to potentially ground-breaking
science and technological innovation. With healthcare undergoing
major transformation, PureTech believes it is well positioned to
develop and launch medicines for the 21st century. For more
information, visit http://www.puretechhealth.com and connect with
us on Twitter.
Forward Looking Statement
This 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.
Enquiries
PureTech
Allison Mead, Associate Director, +1 617 651
Communications and Investor Relations 3156
FTI Consulting (Communications adviser
to PureTech)
Ben Atwell +44 (0) 20
Matthew Cole 3727 1000
This information is provided by RNS
The company news service from the London Stock Exchange
END
NRASSFSIDFMSELI
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