TIDMPRTC
PureTech Health PLC
12 July 2017
12 July 2017
PureTech Health plc
PureTech Health's Gelesis Announces Last Patient Visit in the
Pivotal Gelesis100 Weight-Loss Study
PureTech Health plc ("PureTech", LSE: PRTC), an advanced,
clinical-stage biopharmaceutical company, is pleased to note that
Gelesis, Inc. (a subsidiary of PureTech Health) has completed
treatment of the final patient in the pivotal GLOW (Gelesis Loss Of
Weight) Study. GLOW 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. Results from this
registration-enabling trial are anticipated in Q3 2017.
Gelesis has also enrolled its first European patient in the
ongoing LIGHT-UP study with its second product candidate,
Gelesis200, for weight loss and glycaemic control. LIGHT-UP will
enrol individuals across the United States, Canada, and Europe who
are overweight or have obesity and also have prediabetes or
metformin-treated type 2 diabetes.
Dr. Bharatt Chowrira, President and Chief of Business and
Strategy at PureTech Health, said: "We're delighted to have
achieved these important milestones and to expand the breadth of
the Gelesis platform. As a result of new, preclinical research and
the pioneering work of Gelesis in this emerging field of
mechanobiology, we are also planning or initiating pilot studies
across a number of additional indications including early
nonalcoholic steatohepatitis (NASH), inflammatory bowel disease
(IBD), and other gastrointestinal disorders."
The full text of the announcement from Gelesis is as
follows:
Gelesis Announces Last Patient Out in the Pivotal Gelesis100
Weight-Loss Study
Company also expands to Europe its ongoing study of second
product candidate, Gelesis200, for weight loss and glycaemic
control in people with prediabetes or type 2 diabetes
BOSTON, Massachusetts, July 12, 2017 -- Gelesis, Inc., a
biotechnology company developing a novel category of therapies to
safely induce weight loss, improve glycaemic 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
glycaemic control. The study will enrol 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 glycaemic
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 Gelesis200
Gelesis100 is a pivotal-stage product candidate for weight loss
and glycaemic 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 glycaemic 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 glycaemic 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
glycaemic 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
Recognised 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 Gelesis
Gelesis 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 optimised for weight loss and glycaemic
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).
About PureTech Health
PureTech Health (PureTech Health plc, PRTC.L) is an advanced,
clinical-stage biopharmaceutical company developing novel medicines
targeting serious diseases that result from dysfunctions in the
immune, nervous, and gastro-intestinal systems by intervening early
and addressing the underlying pathophysiology of disease. The
Company is advancing a rich pipeline that includes two pivotal or
registration studies expected to read out in 2017, multiple human
proof-of-concept studies, and a number of early clinical and
pre-clinical programs. PureTech Health's growing research and
development pipeline has been developed in collaboration with some
of the world's leading scientific experts, who along with
PureTech's experienced team and a stellar Board identify, analyse
and advance very selectively the opportunities the Company believes
hold the most promise for patients. This experienced and engaged
team places PureTech Health at the forefront of ground-breaking
science and technological innovation and leads the Company between
and beyond existing disciplines. For more information, visit
www.puretechhealth.com or connect with us on Twitter
@puretechh.
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.
Contact:
PureTech Health FTI Consulting
Allison Mead Ben Atwell, Rob
+1 617 651 3156 Winder
amead@puretechhealth.com +44 (0) 20 3727
1000
This information is provided by RNS
The company news service from the London Stock Exchange
END
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