TIDMPRTC
PureTech Health PLC
04 November 2016
4 November 2016
PureTech Health plc
PureTech's Gelesis Presents New Data at Annual ObesityWeek
Congress
PureTech Health plc ("PureTech", LSE: PRTC), a
cross-disciplinary biotech company developing 21(st) century
medicines, is pleased to note that Gelesis today presented new data
from its proprietary hydrogel platform at ObesityWeek 2016, the
annual combined congress of the American Society for Metabolic and
Bariatric Surgery and The Obesity Society. Data from a
first-in-human study of its second product candidate, Gelesis200,
demonstrated that administration 10 minutes prior to a meal
increased fullness throughout the entire day (P = 0.012) as well as
satiety immediately preceding dinner and at 150 minutes and 180
minutes after dinner (P = 0.032 and P = 0.031, respectively). The
initial safety results of this study were reported in May 2016 and
showed that Gelesis200 was well-tolerated and had a similar safety
profile to placebo.
Pharmacokinetic data from its lead, pivotal-stage product,
Gelesis100, were also presented and showed that administration of
Gelesis100 with metformin hydrochloride 850 mg (immediate release
tablet) was safe, well-tolerated, and affected metformin
pharmacokinetics similarly to food alone.
Joe Bolen, PhD, Chief Scientific Officer for PureTech Health
said: "These clinical results for both Gelesis100 and Gelesis200
represent an important step forward in weight management and
glycaemic control in people who are overweight or have obesity as
well as those who have prediabetes or type 2 diabetes. We look
forward to advancing the Gelesis hydrogel engineering platform to
address important medical needs."
The full text of the announcement from Gelesis is as
follows:
Administration of Gelesis200 Increases Fullness and Satiety in
People who are Overweight or Have Obesity
Data Presented at Annual ObesityWeek Congress
BOSTON, Massachusetts, November 4, 2016 -- Gelesis, focused on
developing first-in-class products to safely induce weight loss and
improve glycaemic control, today presented new data for its second
product candidate, Gelesis200, at ObesityWeek 2016, the annual
combined congress of the American Society for Metabolic and
Bariatric Surgery and The Obesity Society. Data from this
first-in-human study demonstrated that administration 10 minutes
prior to a meal increased fullness throughout the entire day (P =
0.012).
The purpose of the analysis was to determine the effect of
Gelesis200 on subject-reported appetite scores following two or
three administrations in a single day. In addition to increasing
feelings of fullness, administration of Gelesis200 10 minutes prior
to breakfast, lunch, and dinner resulted in greater satiety
immediately preceding dinner (P = 0.017) and at 150 minutes and 180
minutes after dinner (P = 0.032 and P = 0.031, respectively).
Gelesis200 was well-tolerated and its safety profile was similar to
placebo in this study.
"Gelesis200 is the second product comprised from our proprietary
hydrogel platform, and it has been designed specifically for weight
management as well as glycaemic control," said Hassan Heshmati MD,
Gelesis Chief Medical Officer. "Together with the safety and
tolerability results announced earlier this year from the same
study, these new data support the advancement of Gelesis200."
Gelesis also presented pharmacokinetic data for its lead,
pivotal-stage product, Gelesis100, which showed that administration
of Gelesis100 with metformin hydrochloride 850 mg (immediate
release tablet) was safe, well-tolerated, and affected metformin
pharmacokinetics similarly to food alone. Since metformin is
typically administered with food, these results demonstrated that
Gelesis100 could potentially be used safely for weight management
in patients with type 2 diabetes who take metformin.
About Gelesis100
Gelesis100 is a pivotal stage treatment for weight loss and
glycaemic control, which has demonstrated statistically significant
weight loss and safety in its previous studies. The treatment 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. The hydrogel particles, which form a new
chemical entity, are synthesized through Gelesis' multi-step,
proprietary process using starting materials which are considered
Generally Recognized As Safe (GRAS) by the U.S. Food and Drug
Administration (FDA) and commonly used in the food industry.
Gelesis100 capsules are taken with water prior to a meal, after
which the thousands of small hydrogel particles in each capsule 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, inducing weight loss 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 Gelesis200
Gelesis200 leverages the proprietary hydrogel technology of
Gelesis100 but has been engineered with different physical
properties. It takes up slightly less volume than Gelesis100;
however, it has more rapid hydration and greater elasticity and
viscosity. These characteristics are designed to enhance glycaemic
control and weight loss for patients who have prediabetes or type 2
diabetes. Like Gelesis100, Gelesis200 is an orally administered
capsule containing small hydrogel particles synthesized through
Gelesis' multi-step, proprietary process using starting materials
that are considered GRAS by the FDA and commonly used in the food
industry.
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 optimized to induce weight loss and
improve glycaemic control in patients with type 2 diabetes.
The Gelesis advisory team is comprised of 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;
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. Some of these
advisors hold equity in Gelesis.
Gelesis shareholders include Cormorant Asset Management,
PureTech Health PLC (LSE: PRTC), Invesco Asset Management, the
Pritzker/Vlock Family Office, and other prominent biotech and
finance leaders.
PureTech Health plc (PRTC.L) owns 22.5% of the company on a
diluted basis plus potential product royalties as of 30 June 2016.
This calculation includes issued and outstanding shares as well as
options to purchase shares and written commitments to issue shares
or options, but excludes unallocated shares authorised to be issued
pursuant to equity incentive plans.
About PureTech Health
PureTech Health (PureTech Health plc, PRTC.L) is a
cross-disciplinary biotech company creating 21(st) century
medicines that modulate the adaptive human systems. Our therapies
target the immune, nervous, and gastro-intestinal systems by
addressing the underlying pathophysiology of disease from a systems
perspective rather than through a single receptor or pathway. We
are advancing more than 20 clinical studies across our pipeline,
with five human proof-of-concept studies and multiple pivotal or
registration studies expected to read out in the next two years.
PureTech Health's rich and 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 board analyse more than 650 scientific
discoveries per year to identify and advance the opportunities we
believe hold the most promise for patients. This process places
PureTech Health on the cutting edge 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.
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, Director, Communications +1 617 651
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
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