TIDMPRTC
PureTech Health PLC
04 September 2020
4 September 2020
PureTech Health plc
PureTech Founded Entity Gelesis Presents Plenity(R) Efficacy and
Safety Data at the European and International Congress on Obesity
2020
Subgroup analysis showed adults reaching BMI <27 kg/m(2) on
average lost 13.5% of total body weight during the trial
Plenity (Gelesis100) is an 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
Plenity is currently available in the US in limited release with
a full launch in 2021
PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a
clinical-stage biotherapeutics company dedicated to discovering,
developing and commercialising highly differentiated medicines for
devastating diseases, is pleased to note that its Founded Entity,
Gelesis, today announced it will deliver one oral presentation and
two poster presentations showcasing notable efficacy data for
Plenity(R) (Gelesis100) at the European and International Congress
on Obesity (ECO-ICO 2020).
The notable data to be presented in the oral presentation are
from a subgroup analysis from GLOW, a pivotal weight loss study,
assessing the safety and efficacy of Plenity in study participants
reaching a Body Mass Index (BMI) of <27 kg/m(2). The mean BMI at
baseline for this Plenity-treated subgroup was 29.9 +/- 1.56 SD.
Within this subgroup, adults treated with Plenity, on average, lost
13.5% of their total body weight during the trial with the rate of
weight loss tapering as participants approached a healthy BMI.
After achieving a BMI of <27 kg/m(2), participants continued
Plenity treatment for an average of 60 days. The overall safety and
tolerability profile of Plenity within this group was no different
from placebo.
The full text of the announcement from Gelesis is as
follows:
Plenity(R) Efficacy and Safety Data to be Presented at the
European and International Congress on Obesity 2020
Plenity (Gelesis100) is an 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
Plenity is currently available in the US in limited release with
a full launch in 2021
Boston - September 4, 2020 - Gelesis, a biotechnology company
developing a novel hydrogel platform technology to treat
overweight, obesity and other chronic metabolic diseases, announced
it will deliver one oral presentation and two poster presentations
showcasing notable efficacy data for Plenity(R) (Gelesis100) at the
European and International Congress on Obesity (ECO-ICO 2020).
The notable data to be presented in the oral presentation are
from a subgroup analysis from GLOW, a pivotal weight loss study,
assessing the safety and efficacy of Plenity in study participants
reaching a Body Mass Index (BMI) of <27 kg/m(2). The mean BMI at
baseline for this Plenity-treated subgroup was 29.9 +/- 1.56 SD.
Within this subgroup, adults treated with Plenity, on average, lost
13.5% of their total body weight during the trial with the rate of
weight loss tapering as participants approached a healthy BMI.
After achieving a BMI of <27 kg/m(2), participants continued
Plenity treatment for an average of 60 days. The overall safety and
tolerability profile of Plenity within this group was no different
from placebo.
Plenity is an oral, non-systemic therapeutic cleared by the FDA
as an aid for weight management in adults with a BMI of 25-40
kg/m(2) , when used in conjunction with diet and exercise. The
company also received a CE Mark, which enables the marketing of
Plenity in Europe. The novel treatment is administered in the form
of capsules taken with water before lunch and dinner. The capsules
release thousands of particles that rapidly absorb water in the
stomach, creating small individual gel pieces with the elasticity
and firmness of plant-based foods (e.g., vegetables) without
caloric value. The hydrogel contributes to a feeling of fullness
and induces satiety. Plenity is currently available in the US in
limited release with a full launch in 2021.
"Plenity presents both patients and clinicians with the
opportunity for early intervention progression," said Ken Fujioka,
MD, endocrinology researcher at Scripps Clinic and scientific
advisor to Gelesis. "Based on the weight loss achieved in patients
lower in the BMI spectrum, this is a scientifically-validated
option for patients looking to lose as little as 10-15 pounds, or
more."
Details of the data presentations are as follows:
-- Friday, September 4(th) , 7:40AM EDT: Safety of Gelesis100 in
Subjects Who Reached a Body Mass Index Below 27 kg/m(2) in the GLOW
Study; presented by Louis J. Aronne, MD, FACP, Sanford I. Weill
Professor of Metabolic Research, Weill-Cornell Medical College
-- Poster Presentation (EP-459): Safety of Gelesis100 in
Overweight or Obesity: Comprehensive Analysis of the GLOW Study;
Ken Fujioka, MD, Director of the Nutrition and Metabolic Research
Center and the Center for Weight Management, Scripps Clinic
-- Poster Presentation (EP-455): Relevance of Intervention with
Gelesis100 in Overweight and Mild Obesity: a Subgroup Analysis of
the Pivotal GLOW Study; Livio Luzi, MD, Professor of Endocrinology,
University of Milan
Gelesis Loss Of Weight (GLOW) clinical study
The Gelesis Loss Of Weight (GLOW) Study was a randomised,
double-blind, placebo-controlled, parallel-group study enrolling
436 adults with a body mass index (BMI) >= 27 and <= 40
kg/m(2) , including those with prediabetes or type 2 diabetes. The
6-month study compared a 2.25 g dose of Plenity, administered twice
daily, to placebo and was conducted at 33 sites across the United
States and several European countries. Both the active and placebo
arms also included a hypocaloric diet and daily physical activity.
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. 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 from 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(R)
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. Gelesis has also received
approval to market Plenity in the European Economic Area. Plenity
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 and firmness of solid plant-based foods (e.g.,
vegetables) without caloric value. The Plenity hydrogel 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 eliminated through the body's natural digestive
processes. 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 dioxide
-- Plenity may alter the absorption of medications. Read
Sections 6 and 8.3 of the Instructions for Use carefully
-- Avoid use in patients with: esophageal anatomic anomalies,
including webs, diverticuli, and rings; suspected strictures (such
as patients with Crohn's disease); and complications from prior
gastrointestinal (GI) surgery that could affect GI transit and
motility
-- Use with caution in patients with active gastrointestinal
conditions such as gastro-esophageal reflux disease (GERD), ulcers,
or heartburn
-- The overall incidence of AEs in the Plenity group was no different than the placebo group
-- The most common side effects were diarrhea, distended
abdomen, infrequent bowel movements, and flatulence.
For the safe and proper use of Plenity, refer to the US
Instructions for Use or the EU 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
certain chronic diseases. In April 2019, Gelesis received FDA
clearance for its lead product candidate, Plenity(R), 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. It was also granted a CE Mark, which allows Gelesis
to market Plenity in the European Economic Area. Plenity is
currently available in limited release in the US. Additionally,
Gelesis is developing its second investigational 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 in other GI inflammatory
conditions, such as non-alcoholic steatohepatitis (NASH) and
functional constipation. For more information, visit gelesis.com or
connect with us on Twitter @GelesisInc.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercialising highly
differentiated medicines for devastating diseases, including
intractable cancers, lymphatic and gastrointestinal diseases,
central nervous system disorders and inflammatory and immunological
diseases, among others. The Company has created a broad and deep
pipeline through the expertise of its experienced research and
development team and its extensive network of scientists,
clinicians and industry leaders. This pipeline, which is being
advanced both internally and through PureTech's Founded Entities,
is comprised of 24 products and product candidates, including two
that have received US Food and Drug Administration (FDA) clearance
and European marketing authorisation. All of the underlying
programmes and platforms that resulted in this pipeline of product
candidates were initially identified or discovered and then
advanced by the PureTech team through key validation points based
on the Company's unique insights into the biology of the brain,
immune and gut, or BIG, systems and the interface between those
systems, referred to as the BIG Axis.
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:
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
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END
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