Analysis showed that treatment for weight
management with Plenity resulted in NALFD Fibrosis Score
Improvement
These data support further clinical
investigation using Gelesis’ superabsorbent hydrogel platform for
the potential treatment of metabolic-related liver disease
First patient to enroll in a clinical trial
leveraging this platform technology for treatment of NASH/NAFLD
later this year
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) (“PureTech” or the
“Company”), a clinical-stage biotherapeutics company dedicated to
discovering, developing and commercializing highly differentiated
medicines for devastating diseases, is pleased to note that its
Founded Entity, Gelesis, announced today a poster presentation at
the American Association of Clinical Endocrinology (AACE) 2021
Annual Virtual Meeting. The post-hoc analysis showed that treatment
for weight management with Plenity decreased a marker for liver
fibrosis (the NAFLD fibrosis score, or NFS) compared to
placebo.
Plenity is a non-systemic oral superabsorbent hydrogel (OSH)
that is FDA-cleared to aid in weight management in adults with
excess weight or obesity, Body Mass Index (BMI) of 25 to 40 kg/m²,
when used in conjunction with diet and exercise.
This retrospective analysis of Gelesis’ GLOW (Gelesis Loss of
Weight) pivotal study assessed the impact of OSH treatment on liver
health as measured by the NFS, which is intended to predict the
presence of significant fibrosis using common clinical and
laboratory values, including age, BMI, diabetes status, AST/ALT
ratio, platelet count and serum albumin.
The data presented today support the rationale for conducting
further trials to evaluate OSH for the treatment of
metabolic-related liver diseases. Gelesis plans to enroll the first
patient in a clinical study of its OSH GS300 therapeutic candidate
in non-alcoholic steatohepatitis and non-alcoholic fatty liver
disease (NASH/NAFLD) by the end of 2021.
The full text of the announcement from Gelesis is as
follows:
Post-Hoc Analysis Showed Plenity®-Induced
Weight Loss Resulted in NALFD Fibrosis Score Improvement
NAFLD Fibrosis Score (NFS) was developed to
predict the presence of significant fibrosis using common clinical
and laboratory values
The findings were presented today at the
American Association of Clinical Endocrinology’s Annual Meeting
These data support further clinical
investigation using Gelesis’ superabsorbent hydrogel platform for
the potential treatment of metabolic-related liver disease. The
company plans to enroll its first patient in a clinical trial
leveraging this platform technology for the disease later this
year
Boston, May 27, 2021 – Gelesis, a biotechnology company
developing a novel hydrogel platform technology to treat obesity
and other chronic metabolic diseases, released today a poster
presentation at the American Association of Clinical
Endocrinology’s annual meeting. The post-hoc analysis showed that
treatment for weight management with Plenity® decreased a marker
for liver fibrosis (the NAFLD fibrosis score, or NFS) compared to
placebo.
Plenity is a non-systemic oral superabsorbent hydrogel (OSH)
that is FDA-cleared to aid in weight management in adults with
excess weight or obesity, Body Mass Index (BMI) of 25 to 40 kg/m²,
when used in conjunction with diet and exercise.
Gelesis’ portfolio of non-caloric superabsorbent hydrogels is
inspired by the composition and mechanical properties (e.g.
firmness) of raw vegetables. They are conveniently administered in
capsules taken with water to create a much larger volume of small,
non-aggregating hydrogel pieces that become an integrated part of
the meals, and act locally in the digestive system.
This retrospective analysis of Gelesis’ GLOW (Gelesis Loss of
Weight) pivotal study assessed the impact of OSH treatment on liver
health as measured by the NFS, which is intended to predict the
presence of significant fibrosis using common clinical and
laboratory values, including age, BMI, diabetes status, AST/ALT
ratio, platelet count and serum albumin.
NFS was calculated at baseline and at 6 months for 317 study
participants who had all available data at both timepoints. At
baseline, 53.6% of patients receiving Plenity and 53.7% receiving
placebo had a moderate or high NFS. At 6 months, fewer patients had
moderate or high NFS in the Plenity group (45.2), while there was
no change in the placebo group. The absolute numerical change in
score was compared between baseline and 6 months, and a
statistically significant reduction was observed in NFS within the
Plenity group (-.15; p=0.030), but not the placebo group (+0.02;
p=0.824). The difference between groups was statistically
significant (p=0.043).
“These data further emphasize the need to address pre-obesity
with and without comorbidities. Liver health is not always
considered with a weight management plan, and yet early
intervention may help prevent patients from developing
metabolic-related liver disease,” said presenting author Dr.
Christopher Still, DO, FACP, Medical Director for the Center for
Nutrition and Weight Management, and Director for Geisinger Obesity
Research Institute at Geisinger Medical Center. Dr. Still also
participated in the GLOW study.
The data presented today support further trials of OSH treatment
for metabolic-related liver diseases. Gelesis’ plans to enroll the
first patient in a clinical study of its OSH GS300 in non-alcoholic
steatohepatitis and non-alcoholic fatty liver disease, or
NASH/NAFLD, by the end of 2021.
About Gelesis
Gelesis is a consumer-centered biotherapeutics company advancing
a novel category of treatments for weight management and gut
related chronic diseases. Our biomimetic superabsorbent hydrogels
are inspired by the composition and mechanical properties (e.g.
firmness) of raw vegetables. They are conveniently administered in
capsules taken with water to create a much larger volume of small,
non-aggregating hydrogel pieces that become an integrated part of
the meals, and act locally in the digestive system.
Our portfolio includes Plenity, an FDA-cleared product to aid in
weight management, as well as potential therapies in development
for type 2 diabetes, Non-alcoholic Fatty Liver Disease
(NAFLD)/Non-alcoholic Steatohepatitis (NASH), and Functional
Constipation.
For more information, visit gelesis.com, or connect with us on
Twitter @GelesisInc.
About the Gelesis Loss of Weight (GLOW) Clinical
Study
The Gelesis Loss of Weight (GLOW) Study was a randomized,
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 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®
Plenity is FDA-cleared to aid in weight management in adults
with excess weight or obesity, Body Mass Index (BMI) of 25 to 40
kg/m², when used in conjunction with diet and exercise. Plenity is
designed to help you feel full while eating less.
The capsules are taken 20-30 minutes before lunch and dinner
with 16 oz of water, acting locally in the GI tract to make you
feel fuller. Using a novel biomimetic approach, its structure and
properties were inspired by vegetables. Plenity is available now in
a limited release, with broad commercial availability later in
2021.
Important Safety Information
- Patients who are pregnant or are allergic to cellulose, citric
acid, sodium stearyl fumarate, gelatin, or titanium dioxide should
not take Plenity.
- To avoid impact on the absorption of medications:
- For all medications that should be taken with food, take them
after starting a meal.
- For all medications that should be taken without food (on an
empty stomach), continue taking on an empty stomach or as
recommended by your physician.
- The overall incidence of side effects with Plenity was no
different than placebo. The most common side effects were diarrhea,
distended abdomen, infrequent bowel movements, and flatulence.
- Contact a doctor right away if problems occur. If you have a
severe allergic reaction, severe stomach pain, or severe diarrhea,
stop using Plenity until you can speak to your doctor.
Rx Only. For the safe and proper use of Plenity or more
information, talk to a healthcare professional, read the Patient
Instructions for Use, or call 1-844-PLENITY.
For more information, visit myplenity.com.
About PureTech Health
PureTech is a clinical-stage biotherapeutics company dedicated
to discovering, developing and commercializing highly
differentiated medicines for devastating diseases, including
inflammatory, fibrotic and immunological conditions, intractable
cancers, lymphatic and gastrointestinal diseases and neurological
and neuropsychological disorders, 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 26 therapeutics and therapeutic
candidates, including two that have received FDA clearance and
European marketing authorization, as of the date of PureTech’s most
recently filed Annual Report on Form 20-F. All of the underlying
programs and platforms that resulted in this pipeline of
therapeutic 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.
Cautionary Note Regarding Forward-Looking Statements
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, expectations regarding the benefits expected from Plenity based
on the analysis presented at AACE, expectations regarding Gelesis’
plans to enroll the first patient in a clinical study of its OSH
GS300 therapeutic candidate, including the timing thereof, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210527005581/en/
Investors Allison Mead Talbot +1 617 651 3156
amt@puretechhealth.com
PureTech Health (NASDAQ:PRTC)
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