TIDMPRTC
PureTech Health PLC
26 April 2016
26 April 2016
PureTech Health plc
PureTech's Gelesis Announces First U.S. Patient Enrolled in
Pivotal Gelesis100 Weight-Loss Study and Allowance of Key
Patent
U.S. enrolment further advances global pivotal study with 125
European patients having completed study to date
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 the first patient enrolled from the United States (U.S.)
in its pivotal GLOW (Gelesis Loss Of Weight) study. Gelesis also
announced the allowance of a composition of matter patent from the
U.S. Patent and Trademark Office (USPTO) for Gelesis'
technology.
Eric Elenko, Executive Vice President of Science and Technology
at PureTech said: "We are excited to advance the global study of
our proprietary technology, which we hope will help address the
growing obesity epidemic. We have engaged many of the top U.S.
obesity experts as investigators in this study to examine the full
potential of Gelesis100 in adults who are overweight or have
obesity, including those with prediabetes and type 2 diabetes, and
we look forward to potentially bringing a safe and effective
treatment option to those who will benefit from it most."
The full text of the announcement from Gelesis is as
follows:
Gelesis Announces First U.S. Patient Enrolled in Pivotal
Gelesis100 Weight-Loss Study
Company granted U.S. composition of matter patent for Gelesis'
technology
BOSTON, Massachusetts, April 26, 2016 - Gelesis, a biotechnology
company focused on the development of first-in-class products to
safely induce weight loss and improve glycaemic control, today
announced the first patient enrolled from the United States (U.S.)
in its pivotal GLOW (Gelesis Loss Of Weight) study. GLOW will
assess the long-term safety and efficacy of Gelesis100, a novel
oral capsulated device designed to achieve weight loss in adults
who are overweight or have obesity, including those with
prediabetes and type 2 diabetes. GLOW was initiated in November
2014 and has been ongoing at nine clinical trial sites across four
European countries, where 125 patients have completed
treatment.
The company also announced the allowance of a composition of
matter patent from the U.S. Patent and Trademark Office (USPTO) for
Gelesis' technology through 2032.
The Gelesis100 capsule contains small hydrogel particles that,
when taken with water ahead of a meal, is designed to employ
multiple mechanisms of action along the gastrointestinal (GI) tract
to induce weight loss and improve glycaemic control. In a
three-month proof-of-concept study, Gelesis100 demonstrated
statistically significant weight loss and improvement of glycaemic
control in adults who are overweight or have obesity, especially in
those with prediabetes. GLOW will study the impact of Gelesis100 in
achieving weight loss and glycaemic control over a six-month time
period and in a broader patient population, including those who
have type 2 diabetes, across 32 sites in the U.S., Canada and
Europe.
GLOW is a randomised, double-blind, placebo-controlled,
parallel-group study of 460 adults who are overweight or have
obesity (Body Mass Index: 27-40) between the ages of 22 to 65
years, including those with prediabetes and type 2 diabetes. The
study's primary endpoints are placebo-adjusted change in total body
weight from baseline to end of treatment, and percent of
individuals with at least five percent weight loss. The secondary
endpoints include changes in key glycaemic control parameters.
"There is a great need for new, safe therapeutic options that
facilitate both weight loss and glycaemic control, especially in
people with prediabetes," said Gelesis Scientific Advisory Board
member Caroline Apovian, M.D., Professor of Medicine and Pediatrics
at Boston University School of Medicine. "We are excited to study
the Gelesis product in the U.S. with some of the top clinicians in
this field."
Gelesis received positive confirmation from the U.S. Food and
Drug Administration (FDA) in July 2015 that GLOW received a
Non-Significant Risk (NSR) medical device study designation, which
allowed the Company to expand the study to the U.S. The FDA's NSR
designation applies to devices that are generally considered to be
low risk based on their intended use in the study. Examples of NSR
devices include daily wear contact lenses, dental filling materials
and jaundice monitors for infants.
"Enrolling our first patient in the U.S. is an important
milestone as we advance this novel therapeutic as a potentially
effective, non-invasive weight-loss treatment for adults who are
overweight or have obesity," said Hassan Heshmati, M.D., Chief
Medical Officer of Gelesis. "More than two-thirds of U.S. adults
are overweight or obese, so there is a critical need for new
approaches that can help these individuals achieve and maintain a
healthy weight."
Gelesis recently received a Notice of Allowance from the USPTO
for a patent application covering composition of matter. The issued
patent will have a term extending to 2032. Gelesis already owns two
additional patent families with granted or allowed patents in the
US, Europe, Canada, Australia, Japan, Russia, Mexico, China and
Hong Kong. Several other patent families are in different stages of
prosecution.
About Gelesis100
Gelesis100 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 are synthesised
through Gelesis' multi-step, proprietary process using starting
materials which are considered Generally Recognized As Safe (GRAS)
by the FDA and commonly used in the food industry.
Gelesis100 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 100
times their original size. The hydrogel particles mix homogeneously
with food and travel through the GI tract, potentially inducing
satiety and improving glycaemic 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 Gelesis
Gelesis is focused on the development of novel therapies
designed 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 prediabetes and
type 2 diabetes.
The Gelesis executive and advisory team includes 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
Priztker/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 www.puretechhealth.com and connect with us on
Twitter.
Forward Looking Statement
(MORE TO FOLLOW) Dow Jones Newswires
April 26, 2016 04:00 ET (08:00 GMT)
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, Communications
and Investor Relations +1 617 651 3156
FTI Consulting (Communications adviser to PureTech)
Ben Atwell +44 (0) 20 3727
Matthew Cole 1000
This information is provided by RNS
The company news service from the London Stock Exchange
END
NRALIFVDSDIRFIR
(END) Dow Jones Newswires
April 26, 2016 04:00 ET (08:00 GMT)
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