TIDMPRTC
PureTech Health PLC
03 November 2020
3 November 2020
PureTech Health plc
PureTech Founded Entity Gelesis Presents Three Poster
Presentations at ObesityWeek (R) 2020
New data from Gelesis show that pre-diabetes and impaired beta
cell function were associated with a dysfunctional gut barrier, a
potential precursor to metabolic diseases
Additional analysis of Gelesis' pivotal GLOW study suggests
fasting plasma glucose levels and insulin resistance could be
strong predictors of weight loss with Plenity(R)
New in-vitro beverage interaction study finds that Plenity's
hydrogel maintained its properties in the presence of alcoholic or
acidic drinks
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 the release of three poster presentations
at ObesityWeek 2020, the annual congress of The Obesity
Society.
The full text of the announcement from Gelesis is as
follows:
Gelesis Presents Three Poster Presentations at ObesityWeek (R)
2020
New data show that pre-diabetes and impaired beta cell function
were associated with a dysfunctional gut barrier, a potential
precursor to metabolic diseases
Additional analysis of the company's pivotal GLOW study suggests
fasting plasma glucose levels and insulin resistance could be
strong predictors of weight loss with Plenity(R)
New in-vitro beverage interaction study finds that Plenity's
hydrogel maintained its properties in the presence of alcoholic or
acidic drinks
Boston, November 3, 2020 - Gelesis, a biotechnology company
developing a novel hydrogel platform technology to treat
overweight, obesity and other chronic metabolic diseases, announces
the release of three poster presentations at ObesityWeek(R) 2020,
the annual congress of The Obesity Society, including:
-- For the first time, to the authors' knowledge, new data shows
that impaired beta cell function was associated with a
dysfunctional gut barrier, a potential precursor to metabolic
disease;
-- Post-hoc analysis, utilising a novel statistical approach, of
Gelesis' pivotal GLOW study suggests
a connection between weight loss and glycaemic biomarkers;
and
-- An examination of the interaction between a variety of
beverages and Plenity, an oral, non-systemic treatment 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.
"This work presented at ObesityWeek highlights the interplay
between the loss of intestinal barrier integrity and early
beta-cell function, adding to the increased focus of the
gut-pancreatic axis and its critical role on metabolic health,"
said Paresh Dandona, MD, PhD, Distinguished Professor in the
Department of Medicine, Jacobs School of Medicine and Biomedical
Sciences at SUNY Buffalo. "Gelesis is leading the field of research
for intestinal barrier health with its hydrogel technology, with
the goal of becoming a frontline treatment approach that targets
the complex gut-host interaction."
The details of the presentations are as follows.
Poster Presentation (EP-234): Impaired Beta Cell Function is
Associated with Evidence of Dysfunctional Gut Barrier; Husam
Ghanim, PhD; State University of New York, Buffalo, NY
Impaired small intestinal permeability has been linked to
metabolic diseases, including obesity, diabetes, and fatty liver
disease. Intestinal permeability can be measured by drinking a
solution containing various sugars that are typically too large to
be absorbed through the gut barrier. The presence of these sugars
(e.g. cellobiose) in the urine suggest an impairment in gut barrier
function. This analysis is the first, to the authors' knowledge, to
describe an association between increased small intestine
permeability and a reduction in insulin-secreting pancreatic
beta-cell function, as indicated by a reduced insulin response to a
glucose stimulus. Diabetes is already known to have an association
with impaired gut barrier. This new research also suggested a
correlation between fasting plasma glucose (FPG) and gut
permeability, proposing that pre-diabetes is potentially associated
with impaired gut barrier as well. These data also suggest that
intestinal barrier integrity may play an important role in the
treatment of metabolic diseases.
Poster Presentation (EP-174): Evaluating Glucose and Insulin as
Predictors of Weight Loss in GLOW: A Novel Statistical Approach;
Mads Fiil Hjorth, PhD; University of Copenhagen, Frederiksberg,
Denmark
In this post-hoc analysis of the Gelesis Loss of Weight (GLOW)
study, researchers evaluated fasting plasma glucose (FPG) and
fasting plasma insulin (FPI) levels as biomarker predictors for
weight loss with Plenity. The results of this analysis suggest that
for each 1mg/dL increase in FPG, people using Plenity lost 0.10kg
more weight than those on placebo. Similar associations to weight
loss were observed for fasting FPI and HOMA-IR for those
individuals with elevated FPG. The authors conclude that FPG may be
a predictor of weight loss with Plenity treatment, and FPI may also
be an effective predictor, particularly in patients with an
elevated FPG. The results of this analysis are consistent with the
previously reported analysis of the FLOW pilot study, as well as
studies that have demonstrated that patients with impaired FPG lost
more weight than those with normal glycemia when exposed to diets
higher in vegetables, fruits, and whole grains.
Poster Presentation (EP-175): Evaluating the Interaction of an
Oral Superabsorbent Hydrogel with Alcohol and Acidic Beverages;
Damian Bialonczyk, PharmD; Gelesis, Inc., Boston, MA
This presentation details the interaction of Plenity and the
consumption of alcohol and acidic beverages during meals. Plenity
is intended to be taken with 16 ounces of water 20-30 minutes prior
to lunch and dinner. However, some patients may elect to consume
beverages other than water with their meals (after consuming the
recommended 16 oz of water with their Plenity capsules before the
meal). The results of this in-vitro analysis suggest that the
Plenity hydrogel maintains its firmness and water absorption
capacity in the presence of a meal and various alcoholic and acidic
beverages.
About the 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 reduced calorie 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 U.S.
Physician's Instructions for Use or the EU Physician's 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 U.S. Additionally,
Gelesis is developing additional investigational candidates such as
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
Gelesis' 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, our expectations regarding the potential therapeutic benefits
of Plenity and 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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