TIDMPRTC
PureTech Health PLC
05 November 2019
5 November 2019
PureTech Health plc
PureTech Affiliate Gelesis Presents Additional Data Highlighting
Therapeutic Benefits of Plenity(TM) at ObesityWeek 2019
PureTech Health plc (LSE: PRTC) ("PureTech"), a clinical-stage
biotechnology company dedicated to discovering, developing and
commercialising highly differentiated medicines for devastating
diseases, is pleased to note that its affiliate Gelesis presented
two oral presentations and one poster at ObesityWeek 2019, the
annual combined congress of the American Society for Metabolic and
Bariatric Surgery and The Obesity Society in Las Vegas, Nevada,
from 3-7 November 2019. The presentations highlighted the safety
and efficacy of Plenity(TM) (Gelesis100), including a new post-hoc
analysis of the pivotal Gelesis Loss of Weight (GLOW) trial, which
found that Plenity-treated adults who achieved a BMI of 27 or less
lost an average of 13.5% of their weight, with the rate of weight
loss tapering as participants approached a healthy BMI goal. The
newly presented analysis also showed that twice as many adults
(11%) reached a BMI of 27 kg/m(2) when treated with Plenity as
compared to placebo (5%). Plenity is the only prescription
therapeutic cleared by the FDA for use in overweight adults with a
BMI below 30 kg/m(2) , with or without comorbidities such as
hypertension, type 2 diabetes, and dyslipidaemia.
Eric Elenko, PhD, chief innovation officer at PureTech, said:
"These new data further highlight the unique opportunity Plenity
offers a broad range of adults who are struggling to achieve a
healthy weight."
The full-text announcement from Gelesis is as follows:
Pivotal Data Presented at ObesityWeek 2019 Highlight the
Therapeutic Benefits of Plenity(TM) in Adults with Obesity and
Underscore its Safety and Efficacy in Lower-BMI Overweight
Adults
Plenity-treated adults achieving a BMI of <27 lost an average
of 13.5% of their weight with the rate of weight loss tapering as
participants approached a healthy BMI goal
Twice as many adults reached a BMI of 27 or less when treated
with Plenity compared to placebo
No increased safety risk observed in lower BMI adults (<35),
with the overall incidence of treatment-related adverse events no
different from placebo
BOSTON, Nov. 5, 2019 - Gelesis, a biotechnology company
developing a novel hydrogel platform technology to treat obesity
and other chronic diseases related to the gastrointestinal (GI)
tract, today announced results of a new post-hoc analysis from the
Gelesis Loss of Weight (GLOW) clinical trial for participants
achieving a Body Mass Index (BMI) of 27 kg/m(2) or less. These data
showed that twice as many adults (11%) lost enough weight to
achieve a BMI of 27 or less when treated with Plenity(TM)
(Gelesis100) than when treated with placebo (5%). Plenity is an
oral, non-systemic, superabsorbent hydrogel that rapidly absorbs
water in the stomach and mixes homogeneously with ingested foods to
increase the volume and elasticity of the stomach and small
intestine contents. Consistent with the larger GLOW cohort, the
overall incidence of adverse events (AEs) in lower-BMI adults
treated with Plenity was no different from placebo treatment. The
results were shared in an oral session at ObesityWeek 2019, the
annual combined congress of the American Society for Metabolic and
Bariatric Surgery and The Obesity Society.
Less than half of the approximately 150 million adults in the
U.S. struggling with overweight and obesity (BMI 25 kg/m(2) to 40
kg/m(2) ) meet the clinical threshold for obesity (BMI > 30
kg/m(2) ). Yet the health burden of excess weight begins before the
onset of obesity, with approximately 40% of BMI-related deaths in
2015 occurring in overweight adults with a BMI <30 kg/m(2) .
Studies show even modest weight gain in early adulthood is strongly
associated with critical outcomes such as cancer risk and
mortality.
"In order to break the cycle of adult obesity and have a
meaningful impact on both individual and population health, we
should shift the treatment paradigm to prevent obesity by treating
patients when they are overweight and before they meet the clinical
definition of obesity," said Ken Fujioka, MD, a weight loss expert,
endocrinology researcher at Scripps Clinic and scientific advisor
to Gelesis. "This subgroup analysis provides clear and compelling
insight into the safety and efficacy of Plenity treatment in
overweight patients with a lower-BMI, and - in conjunction with the
exciting results from the overall study - provide a strong
rationale for Plenity as an early therapeutic intervention for
adults with excess weight."
During an oral presentation at ObesityWeek 2019, study
investigators delivered data from a new subgroup analysis of the
Glow study assessing the safety and efficacy of Plenity in study
participants reaching a 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 in approximately 100 days 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.
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/m2, 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. 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 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(TM) (Gelesis100)
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 the only prescription
therapeutic cleared by the FDA for use in overweight adults with a
BMI below 30 kg/m(2) , with or without comorbidities such as
hypertension, type 2 diabetes, and dyslipidaemia. 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 (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 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, with 38% of adults in the Plenity group
and 28% of adults in the placebo group.
-- The overall incidence of adverse events (AEs) in the Plenity
group was no different from 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
certain 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 anticipates Plenity will be available by
prescription in the U.S. in the second half of 2020. 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
Chronic Idiopathic Constipation (CIC).
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 clinical-stage biotechnology company
dedicated to discovering, developing and commercialising highly
differentiated medicines for devastating diseases. For more
information, visit gelesis.com or connect with us on Twitter
@GelesisInc.
About PureTech
PureTech is a clinical stage biotechnology 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 affiliates, is comprised of 24 product
candidates and one product that has been cleared by the US Food and
Drug Administration (FDA). 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, strategies and
expectations. 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 Tom Donovan
+1 617 651 3156 +44 (0) 20 3727 1000 +1 857 559 3397
amt@puretechhealth.com ben.atwell@FTIconsulting.com tom@tenbridgecommunications.com
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END
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