TIDMPRTC
PureTech Health PLC
06 June 2022
6 June 2022
PureTech Health plc
PureTech Founded Entity Gelesis Presents Study of Proprietary
Hydrogel That Demonstrates How Gut Bacteria Contributes to Weight
Loss and Beneficial Metabolic Effects
New preclinical data presented at the American Diabetes
Association's annual conference suggests that Gelesis'
superabsorbent hydrogel causes changes to the microbiota leading to
weight loss and improvements in glucose tolerance and insulin
sensitivity
PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the
"Company"), a clinical-stage biotherapeutics company announced that
its Founded Entity, Gelesis Holdings, Inc. (NYSE: GLS) ("Gelesis"),
a consumer-focused biotherapeutics company and the maker of
Plenity(R) for weight management, presented new preclinical data
showing weight loss and additional metabolic benefits in mice
receiving a microbiota transplant from another group of mice,
treated with one of the company's proprietary hydrogels. These
metabolic benefits occurred while both groups of mice, the donors
of the microbiota transplant and the recipient mice, were on a high
fat, high carbohydrate diet typically causing rapid weight gain,
obesity, and diabetes. The findings were presented on Saturday at
the American Diabetes Association's annual conference.
The study used intestinal microbiota transfer (IMT) to
investigate the functional role of the gut microbiota to explain
the metabolic effects associated with Gel-B treatment. Metabolic
disease was induced in two cohorts of mice ("Donors" and
"Recipients") via consumption of a high fat, high cholesterol, high
carbohydrate (HFHCC) diet for 10 weeks. Donors either continued
HFHCC or were treated with HFHCC plus Gel-B for 6 additional weeks.
Fecal samples were processed from Donors every other day during
weeks 2-6 of treatment. Recipients received either intestinal
microbiota transfer from Gel-B-treated or untreated Donors.
Recipients receiving IMT from untreated Donors continued to gain
weight, while Recipients receiving IMT from Gel-B treated Donors
lost weight, despite the continued consumption of HFHCC. Treating
the recipients with intestinal microbiota of Gel B treated donors
also resulted in improvement in glycemic control.
The full text of the announcement from Gelesis is as
follows:
Microbiota Transplantation Demonstrates How Gut Bacteria
Contributes to Weight Loss and Beneficial Metabolic Effects with
Gelesis' Proprietary Hydrogel
New preclinical data presented today at the American Diabetes
Association's annual conference suggests that the company's
superabsorbent hydrogel causes changes to the microbiota leading to
weight loss and improvements in glucose tolerance and insulin
sensitivity
BOSTON, JUNE 4, 2022 - Gelesis (NYSE: GLS), the maker of Plenity
for weight management, presented new preclinical data showing
weight loss and additional metabolic benefits in mice receiving a
microbiota transplant from another group of mice, treated with one
of the company's proprietary hydrogels. These metabolic benefits
occurred while both groups of mice, the donors of the microbiota
transplant and the recipient mice, were on a high fat, high
carbohydrate diet typically causing rapid weight gain, obesity, and
diabetes. The findings were presented today at the American
Diabetes Association's annual conference.
Gelesis' superabsorbent hydrogels are inspired by the
composition (cellulose structures holding water) and mechanical
properties (elasticity or firmness) of ingested raw vegetables.
They are taken by capsules with water before a meal to create a
much larger volume of small, non-aggregating hydrogel pieces that
act locally in the digestive system without adding any additional
calories. One of the hydrogels is commercially available as
Plenity(R) to aid in weight management; others that utilize the
same platform technology are in clinical and preclinical
studies.
In April, Gelesis presented preclinical data at the World of
Microbiome conference suggesting that adding superabsorbent
hydrogel (Gel-B, an investigational candidate) to a high-fat
"western-like" diet prevents unfavorable changes in the communities
of gut bacteria associated with diet-induced weight gain. The study
showed a striking effect on gut microbiota composition with
enrichment of several key bacteria such as Akkermansia muciniphila,
a bacterial species associated with gut health and weight loss.
Importantly, an addible fiber (a modified cellulose), used as a
positive control, did not support the growth of these species. This
same type of modified cellulose is used to create Gelesis'
proprietary hydrogels. The difference in bacterial growth between
the linear fiber and the 3-dimensional hydrogel suggests that the
effects of the hydrogel on the microbiota are mainly mechanical
(i.e. elastic response or firmness). In previous studies,
administration of one of these hydrogels, in addition to a high-fat
diet, blunted weight gain, reversed gut atrophy, improved metabolic
parameters, and restored gut barrier.
This new study aimed to investigate whether transferring the
microbiota from Gel B-treated mice into the gut of mice fed a high
fat, high carbohydrate, high cholesterol (HFHCC) diet for 10 weeks
could alleviate the detrimental effects of their diet.
"This study provides strong evidence that the modulation of the
gut microbiome by Gelesis' superabsorbent hydrogel likely plays a
mechanistic role in the weight loss and metabolic impact of this
intervention," said Maria Rescigno, PhD, Group Leader of the
Mucosal Immunology and Microbiota Unit at Humanitas University in
Milan, and one of the lead investigators on the study. "We found
that the microbiota from animals with obesity consuming a high-fat
diet can be modified with Gel-B treatment to become a 'lean
microbiota.' We then found that this Gel-B induced lean microbiota
was transmissible, as it caused weight loss in mice with obesity
that were not treated by Gel-B."
The study used intestinal microbiota transfer (IMT) to
investigate the functional role of the gut microbiota to explain
the metabolic effects associated with Gel-B treatment. Metabolic
disease was induced in two cohorts of mice ("Donors" and
"Recipients") via consumption of a high fat, high cholesterol, high
carbohydrate diet for 10 weeks. Donors either continued HFHCC or
were treated with HFHCC plus Gel-B for 6 additional weeks. Fecal
samples were processed from Donors every other day during weeks 2-6
of treatment. Recipients received either intestinal microbiota
transfer from Gel-B-treated or untreated Donors. Recipients
receiving IMT from untreated Donors continued to gain weight, while
Recipients receiving IMT from Gel-B treated Donors lost weight,
despite the continued consumption of HFHCC. Treating the recipients
with intestinal microbiota of Gel B treated donors also resulted in
improvement in glycemic control.
An interview with study author Dr. Rescigno is available at
https://youtu.be/AsmUo7lnQbs.
About Gelesis
Gelesis Holdings Inc. (NYSE: GLS) ("Gelesis") is a
consumer-centered biotherapeutics company and the maker of
Plenity(R), which is inspired by nature and FDA cleared to aid in
weight management. Our first-of-their-kind non-systemic
superabsorbent hydrogels are made entirely from naturally derived
building blocks. They are inspired by the composition and
mechanical properties of raw vegetables, taken by capsule, and act
locally in the digestive system, so people feel satisfied with
smaller portions. Our portfolio includes Plenity(R) and potential
therapies in development for patients with 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.
Plenity(R) is indicated to aid weight management in adults with
excess weight or obesity, a Body Mass Index (BMI) of 25-40 kg/m(2),
when used in conjunction with diet and exercise.
Important Safety Information about Plenity
-- 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:
o For all medications that should be taken with food, take them
after starting a meal.
o 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.
Forward-Looking Statements
Certain statements, estimates, targets and projections in this
press release may constitute "forward-looking statements" within
the meaning of the federal securities laws. The words "anticipate,"
"believe," continue," "could," "estimate," "expect," "intend,"
"may," "might," "plan," "possible," "potential," "predict,"
"project," "should," "strive," "would" and similar expressions may
identify forward-looking statements, but the absence of these words
does not mean that statement is not forward looking.
Forward-looking statements are predictions, projections and other
statements about future events that are based on current
expectations and assumptions and, as a result, are subject to risks
and uncertainties. Forward-looking statements include, but are not
limited to, statements regarding our or our management team's
expectations, hopes, beliefs, intentions or strategies regarding
the future, including those relating to Gelesis' business
combination with Capstar Special Purpose Acquisition Corp.
("Capstar") and its expected benefits, Gelesis' performance
following the business combination, the competitive environment in
which Gelesis operates, the expected future operating and financial
performance and market opportunities of Gelesis and statements
regarding Gelesis' expectations, hopes, beliefs, intentions or
strategies regarding the future. In addition, any statements that
refer to projections, forecasts, or other characterizations of
future events or circumstances, including any underlying
assumptions, are forward-looking statements. Forward-looking
statements speak only as of the date they are made. Readers are
cautioned not to put undue reliance on forward-looking statements,
and Gelesis assumes no obligation and does not intend to update or
revise these forward-looking statements, whether as a result of new
information, future events, or otherwise. Gelesis gives no
assurance that any expectations set forth in this press release
will be achieved. Various risks and uncertainties (some of which
are beyond our control) or other factors could cause actual future
results, performance or events to differ materially from those
described herein. Some of the factors that may impact future
results and performance may include, without limitation: (i) the
size, demand and growth potential of the markets for Plenity(R) and
Gelesis' other product candidates and Gelesis' ability to serve
those markets; (ii) the degree of market acceptance and adoption of
Gelesis' products; (iii) Gelesis' ability to develop innovative
products and compete with other companies engaged in the weight
loss industry; (iv) Gelesis' ability to finance and complete
successfully the commercial launch of Plenity(R) and its growth
plans, including new possible indications and the clinical data
from ongoing and future studies about liver and other diseases; (v)
failure to realize the anticipated benefits of the business
combination, including as a result of a delay or difficulty in
integrating the businesses of Capstar and Gelesis; (vi) the ability
of Gelesis to issue equity or equity-linked securities or obtain
debt financing in the future; (vii) the outcome of any legal
proceedings instituted against Capstar, Gelesis, or others in
connection with the business combination; (viii) the ability of
Gelesis to maintain its listing on the New York Stock Exchange;
(ix) the risk that the business combination disrupts current plans
and operations of Gelesis as a result of Gelesis being a publicly
listed issuer; (x) the regulatory pathway for Gelesis' products and
responses from regulators, including the FDA and similar regulators
outside of the United States; (xi) the ability of Gelesis to grow
and manage growth profitably, maintain relationships with customers
and suppliers and retain Gelesis' management and key employees;
(xii) costs related to the business combination, including costs
associated with the Gelesis being a publicly listed issuer; (xiii)
changes in applicable laws or regulations; (xiv) the possibility
that Gelesis may be adversely affected by other economic, business,
regulatory and/or competitive factors; (xv) Gelesis' estimates of
expenses and profitability; (xvi) ongoing regulatory requirements,
(xvii) any competing products or technologies that may emerge,
(xviii) the volatility of the telehealth market in general, or
insufficient patient demand; (xix) the ability of Gelesis to defend
its intellectual property and satisfy regulatory requirements; (xx)
the impact of the COVID 19 pandemic on Gelesis' business; (xxi) the
limited operating history of Gelesis; (xxii) the potential impact
of inflation on our operating expenses and costs of goods; and
(xxiii) other important factors discussed in the "Risk Factors"
section of Gelesis' most recent Annual Report on Form 10-K, and in
other filings that Gelesis makes with the Securities and Exchange
Commission. These filings address other important risks and
uncertainties that could cause actual results and events to differ
materially from those contained in the forward-looking
statements.
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 27
therapeutics and therapeutic candidates, including two that have
received both U.S. FDA clearance and European marketing
authorization, as of the date of PureTech's most recently filed
Annual Report and corresponding Form 6-K. 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 unique insights in immunology and drug development.
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 within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements contained
in this press release that do not relate to matters of historical
fact should be considered forward-looking statements, including
without limitation statements that relate to the business
combination agreement between Gelesis and Capstar Special Purpose
Acquisition Corp. (NYSE: CPSR) or matters related thereto, the
potential of Gel-B to become a foundational treatment, and Gelesis'
future prospects, development plans, and strategies. The
forward-looking statements are based on current expectations and
are subject to known and unknown risks, uncertainties and other
important factors that could cause actual results, performance and
achievements to differ materially from current expectations,
including, but not limited to, those risks, uncertainties and other
important factors described under the caption "Risk Factors" in our
Annual Report on Form 20-F for the year ended December 31, 2021
filed with the SEC and in our other regulatory filings. 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, we
disclaim any obligation to update or revise these forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contact:
PureTech
Public Relations
publicrelations@puretechhealth.com
Investor Relations
IR@puretechhealth.com
EU Media
Ben Atwell, Rob Winder
+44 (0) 20 3727 1000
ben.atwell@FTIconsulting.com
U.S. Media
Nichole Sarkis
+1 774 278 8273
nichole@tenbridgecommunications.com
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