TIDMPRTC
RNS Number : 1235W
PureTech Health PLC
15 April 2019
15 April 2019
PureTech Health plc
PureTech Health Affiliate Gelesis Announces Successful FDA
Milestone for First Product, PLENITY(TM)
FDA Clearance of PLENITY(TM) is a landmark milestone for
PureTech Health, which helped conceive and develop the platform
PLENITY is FDA cleared for the largest number of adults
struggling with overweight and obesity (BMI 25-40 kg/m(2) ) of any
prescription weight-management aid and the first that can be used,
along with diet and exercise, in millions of overweight adults who
have never before had prescription options
6 out of 10 adults treated with PLENITY were responders, losing
on average 10% of their weight (22 pounds) and 3.5 inches from
their waists within 6 months in pivotal study
PLENITY is a new orally administered, non-stimulant,
non-systemic aid in weight management based on proprietary hydrogel
technology with a highly favourable safety and efficacy profile
demonstrated in clinical studies
Webcast and conference call today at 12:00PM BST / 7:00AM
EDT
PureTech Health plc (LSE: PRTC) ("PureTech Health"), an advanced
biopharmaceutical company developing novel medicines for
dysfunctions of the Brain-Immune-Gut (BIG) axis, today announced
that its affiliate, Gelesis, has received marketing clearance from
the United States Food and Drug Administration (FDA) for its first
product, PLENITY(TM) (Gelesis100), a new and differentiated aid in
weight management in adults with a Body Mass Index (BMI) of 25-40
kg/m(2) , when used in conjunction with diet and exercise. Nearly
150 million adults in the United States fall into this wide BMI
range. PLENITY is the only prescription weight management product
to be cleared for use by overweight adults with a BMI as low as 25
kg/m(2) , with or without comorbidities such as hypertension, type
2 diabetes or dyslipidaemia.
PLENITY is an orally administered capsule containing a
non-stimulant, non-systemic, superabsorbent hydrogel. It is
designed to absorb water and increase the volume and elasticity of
the stomach and small intestine contents to help people feel full.
Gelesis plans to initiate a targeted U.S. launch of PLENITY in the
second half of 2019 and anticipates PLENITY will be broadly
available by prescription in the U.S. in 2020.
Eric Elenko, PhD, co-founder and chief innovation officer at
PureTech Health, said: "This FDA clearance of PLENITY(TM) marks a
major accomplishment for PureTech Health and Gelesis. We
congratulate the Gelesis team for bringing a truly novel approach
for weight management to a vast population of people who have had
limited or no prescription treatment options until now. The
experienced commercial team at Gelesis is well-positioned to launch
this exciting new therapy along with a deep base of investors who
will help to support the launch.
"In-line with PureTech's overarching scientific focus and
leadership in the BIG axis, Gelesis is developing its novel
hydrogel platform technology for other chronic diseases such as
non-alcoholic steatohepatitis and inflammatory bowel disease
through its proprietary approach focused on modulating the
gastrointestinal pathway.
"Committed to developing innovative medicines to address some of
the largest health issues facing society today, PureTech Health has
developed seven novel platforms from concept to clinical validation
across our affiliate pipeline. FDA clearance of PLENITY is a
landmark moment, providing strong validation of PureTech's ability
to identify and develop an emerging area of biology into a new
category of medicine for diseases with significant patient need. We
look forward to building on this significant milestone with the
many upcoming catalysts across our internal and affiliate
pipelines."
Webcast and conference call today at 12:00PM BST, 7:00AM EDT
Members of the Gelesis and PureTech Health senior management
teams will host a conference call at 12:00PM BST / 7:00AM EDT
today, 15 April, to discuss this announcement. A live webcast of
the conference call and presentation slides will be available on
the investors section of PureTech's website
(http://puretechhealth.com/investors) under the Reports and
Presentations tab. To join the conference call please dial:
UK Toll Free Number: 0800 368 2276
US Toll Free Number: 1 866 966 5335
Standard International Access: +44 (0) 20 3037 9315
Participants should log on approximately 10 minutes in advance
to download slides and ensure proper setup to receive the webcast.
For those unable to listen to the call live, a replay will be
available on the PureTech Health website following the call.
The full text announcement from Gelesis is as follows:
Gelesis Granted FDA Clearance to Market PLENITY(TM) - a New
Prescription Aid in Weight Management
PLENITY is FDA cleared for the largest number of adults
struggling with overweight and obesity (BMI 25-40 kg/m(2) ) of any
prescription weight-management aid and the first that can be used,
along with diet and exercise, in millions of overweight adults who
have never before had prescription options
6 out of 10 adults treated with PLENITY were responders, losing
on average 10% of their weight (22 pounds) and 3.5 inches from
their waists within 6 months in pivotal study
PLENITY is a new orally administered, non-stimulant,
non-systemic aid in weight management based on proprietary hydrogel
technology with a highly favourable safety and efficacy profile
demonstrated in clinical studies
BOSTON, April 14, 2019 - Gelesis, a biotechnology company
developing first-in-class hydrogel therapeutics to treat obesity
and other chronic diseases related to the gastrointestinal (GI)
tract, today announced that the United States Food and Drug
Administration (FDA) has cleared the Company's lead product
candidate, PLENITY(TM) (Gelesis100), as an aid in weight management
in adults with a Body Mass Index (BMI) of 25-40 kg/m(2) , when used
in conjunction with diet and exercise. A BMI of 25 kg/m(2) and over
is the accepted definition of overweight, and a BMI of 30 kg/m(2)
and above commonly defines obesity.
PLENITY represents a new prescription option for millions of
adults. More than half of the approximately 150 million adults in
the U.S. with a BMI ranging from 25 kg/m(2) to 40 kg/m(2) are
classified as overweight (BMI 25-30 kg/m(2) ). Until now, many of
them have not had any prescription treatment options. The safety
and efficacy profile of PLENITY makes it well-suited for these
individuals. It is the only prescription weight management product
to be cleared for use by overweight adults with a BMI as low as 25
kg/m(2) , with and also without comorbidities such as hypertension,
type 2 diabetes or dyslipidemia. There is no restriction on how
long PLENITY can be used to assist in weight management.
"This FDA clearance is a major milestone for the Gelesis team
and our technology, and we are thrilled to be able to bring this
new prescription product to the millions of people looking for a
safe, validated and convenient treatment option to manage their
weight without surgery or stimulants," said Yishai Zohar, founder
and chief executive officer of Gelesis. "With PLENITY, Gelesis is
introducing a completely new approach with a unique mechanism of
action to aid in weight management, with efficacy and safety
supported by positive data from large clinical studies."
PLENITY is administered in the form of capsules taken with water
before lunch and dinner. PLENITY is made by cross-linking two
naturally-derived building blocks - cellulose and citric acid - to
create a three-dimensional hydrogel matrix. The capsules release
thousands of non-aggregating particles that rapidly absorb water in
the stomach, creating small individual gel pieces with the
elasticity (firmness) of plant-based foods (e.g., vegetables)
without caloric value. The gel pieces increase the volume and
elasticity of the stomach and small intestine contents,
contributing to a feeling of fullness and inducing weight loss.
This novel, non-stimulant and non-systemic treatment has been shown
in clinical studies to be effective, safe and well-tolerated.
In clinical studies, PLENITY demonstrated a unique combination
of effectiveness combined with a highly favourable safety and
tolerability profile. Data from the PLENITY pivotal study, Gelesis
Loss Of Weight (GLOW), were published recently in the scientific
journal Obesity and that paper was selected as an Editor's Choice
manuscript. Pivotal data from the GLOW study were also presented in
three posters, one receiving a special recognition award, and an
oral presentation at the Obesity Society Annual Meeting 2018.
"Given the complexity of the disease of obesity and the need for
expanded treatment options, the Obesity Action Coalition is
encouraged to see continued innovation in safe and effective
chronic weight management options. We welcome PLENITY's addition as
a treatment option for people affected by obesity," said Joe
Nadglowski, president and chief executive officer of the Obesity
Action Coalition.
"More than 150 million Americans struggle with excess or
unhealthy weight. Unfortunately, the majority of individuals with
weight issues have important weight-related medical problems. There
is no doubt that making a significant impact on this issue should
be America's number one public health priority. The scientific data
supporting PLENITY's positive effects on weight make it a powerful
tool to help with weight management. The most compelling aspects of
this approach are its effectiveness, novel mechanism of action and
impressive safety data. This approach creates another arm in the
treatment algorithm of weight management and could be used by an
overwhelming majority of people struggling with weight issues,"
said Ken Fujioka, M.D., a weight loss expert, endocrinology
researcher at Scripps Clinic and scientific advisor to Gelesis.
Gelesis plans to initiate a targeted U.S. launch of PLENITY in
the second half of 2019 and anticipates PLENITY will be broadly
available by prescription in the U.S. in 2020.
Clinical studies of PLENITY
PLENITY and its prototypes have been studied across five
clinical studies throughout the United States, Canada, and Europe.
PLENITY, along with diet and exercise, helps to induce weight loss
through increased satiety and reduced hunger, leading to a
reduction in caloric intake. Throughout its clinical programme,
PLENITY has demonstrated a consistently strong safety and efficacy
profile.
PLENITY was recently evaluated in a multicentre, double-blind,
placebo-controlled pivotal study designed to assess change in body
weight in 436 adults with overweight or obesity (BMI >= 27 and
<= 40 kg/m(2) ) after six months of treatment. The study had two
predefined co-primary endpoints: at least 35% of patients taking
PLENITY achieving >= 5% weight loss (categorical endpoint) and
placebo-adjusted weight loss with a super-superiority margin of 3%.
In addition, a prespecified analysis of simple superiority was also
performed. The study met and exceeded the predefined categorical
endpoint, with 59% of adults in the treatment group achieving
weight loss of 5% or greater. As previously announced, the study
did not meet the 3% super-superiority endpoint but demonstrated
superiority of the PLENITY treatment over the placebo group (-6.4%
vs. -4.4%, P=0.0007). PLENITY-treated individuals had twice the
odds of achieving at least 5% weight loss vs. placebo (adjusted
odds ratio [OR]: 2.0, P=0.0008).
In addition, 26% of the adults who completed the treatment with
PLENITY were "super-responders," defined as achieving at least 10%
weight loss. These super-responders achieved an average of about
14% weight loss or approximately 30 pounds.
The overall incidence of adverse events (AEs) in the PLENITY
treatment group was no different than placebo. The most common
treatment related adverse events (TRAEs) were gastrointestinal
disorders (158 TRAEs in 84 [38%] subjects in the PLENITY arm,
compared to 105 events in 58 [28%] subjects receiving placebo),
infections and infestations (2 events in 2 [1%] subjects with
PLENITY and 1 events in 1 [1%] subjects with placebo), and
musculoskeletal and connective tissue disorders (3 events in 2 [1%]
subjects with PLENITY and 0 in 0 [0%] subjects with placebo). There
were no serious adverse events (SAE) in the PLENITY treatment
group, whereas there was one (1) SAE in the placebo treatment
group.
About PLENITY(TM)
PLENITY is an oral, non-systemic, superabsorbent hydrogel which
has received FDA clearance as an aid in weight management in
overweight and obese adults with a BMI of 25-40 kg/m(2) , when used
in conjunction with diet and exercise. It is made by cross-linking
two naturally derived building blocks, modified cellulose and
citric acid, that create a three-dimensional matrix. PLENITY
particles rapidly absorb water in the stomach and homogenously mix
with ingested foods. Rather than forming one large mass, it creates
thousands of small individual gel pieces with the elasticity
(firmness) of solid plant-based foods (e.g., vegetables) without
caloric value. The PLENITY hydrogel mass increases the volume and
elasticity of the stomach and small intestine contents and induces
a feeling of fullness and satiety. 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
faeces. PLENITY is considered a medical device because it achieves
its primary intended purpose through mechanical modes of action
consistent with mechanobiology constructs. For more information,
visit myplenity.com.
Important Safety Information
-- PLENITY is contraindicated in patients who are pregnant or
are allergic to cellulose, citric acid, sodium stearyl fumarate,
gelatin, or titanium oxide
-- PLENITY may alter the absorption of medications. Read
Sections 6 and 8.3 of the Instructions for Use carefully
-- Avoid use in patients with the following conditions:
esophageal anatomic anomalies, including webs, diverticuli, and
rings; suspected strictures (such as patients with Crohn's
disease); or complications from prior gastrointestinal (GI) surgery
that could affect GI transit and motility.
-- Use with caution in patients with: active GI conditions such
as gastro-esophageal reflux disease (GERD), ulcers, or
heartburn.
-- Overall, the most common treatment related adverse events
(TRAEs) were GI-related TRAEs with 38% of adults in the PLENITY
group and 28% of adults in the placebo group experiencing a
GI-related TRAE.
-- The overall incidence of AEs in the PLENITY group was no different than the placebo group
Rx Only. For the safe and proper use of PLENITY, refer to the
Instructions for Use.
About Gelesis
Gelesis is developing a novel hydrogel platform technology to
treat overweight and obesity and 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 April 2019, Gelesis received FDA clearance for
its lead product candidate, PLENITY(TM) , as an aid for weight
management in overweight and obese adults with a Body Mass Index
(BMI) of 25-40 kg/m(2) , when used in conjunction with diet and
exercise. Gelesis is preparing to initiate a targeted U.S. launch
of PLENITY in the second half of 2019 and anticipates PLENITY will
be broadly available by prescription in the U.S. in 2020.
Additionally, Gelesis is developing its second candidate,
Gelesis200, a hydrogel optimised for weight loss and glycaemic
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 in other GI
inflammatory conditions where gut barrier and gut permeability
potentially play a role, such as 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, materials science, chronic
disease research and commercialisation. Gelesis was co-founded by
PureTech Health (LSE: PRTC), a biopharmaceutical company focused on
the Brain-Immune-Gut (BIG) axis. For more information, visit
gelesis.com or connect with us on Twitter @GelesisInc.
About PureTech Health
PureTech Health (LSE: PRTC) is an advanced biopharmaceutical
company developing BIG medicines for dysfunctions of the
Brain-Immune-Gut axis. The Company has gained deep insights into
the connection between these systems and the resulting role in
diseases that have proven resistant to established therapeutic
approaches. By harnessing this emerging field of human biology,
PureTech Health is developing new categories of medicines with the
potential to have great impact on people with serious diseases.
PureTech Health is advancing a rich pipeline of innovative
therapies with an unbiased, non-binary, and capital efficient
R&D model across its affiliates and its internal labs.
PureTech's affiliates include seven clinical-stage platforms,
including one product that has been cleared by the US Food and Drug
Administration (FDA) and a second product candidate that has been
filed with the FDA for review, and several other novel preclinical
programmes. The PureTech Health pipeline includes ground-breaking
platforms and therapeutic candidates that were developed in
collaboration with some of the world's leading experts.
PureTech's internal research and development is centred on
tissue-selective immunomodulation for the treatment of oncology,
autoimmune, and CNS-related disorders, with a near-term focus on
targeting newly-discovered, foundational immunosuppressive
mechanisms in oncology and novel approaches that harness the
lymphatic infrastructure.
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.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
Contact:
Investors EU media US media
Allison Mead Talbot Ben Atwell, Rob Winder Stephanie Simon
+1 617 651 3156 +44 (0) 20 3727 1000 +1 617 581 9333
amt@puretechhealth.com ben.atwell@FTIconsulting.com stephanie@tenbridgecommunications.com
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
REAGMGMDVDNGLZM
(END) Dow Jones Newswires
April 15, 2019 02:00 ET (06:00 GMT)
Puretech Health (LSE:PRTC)
Historical Stock Chart
From Jun 2024 to Jul 2024
Puretech Health (LSE:PRTC)
Historical Stock Chart
From Jul 2023 to Jul 2024