New preclinical data presented today at the
World of Microbiome Conference suggest adding superabsorbent
hydrogel to a high-fat “western-like” diet prevents unfavorable
changes in the communities of gut bacteria associated with
diet-induced weight gain
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),
released today a poster prPesentation at the World of Microbiome
annual meeting in Vienna. The preclinical study showed
administration of one of Gelesis’ proprietary superabsorbent
hydrogels, Gel-B, significantly shifted the composition of the
microbiome to a profile correlated with better metabolic health,
including improved weight and glucose control. Adding Gel-B to a
high-fat diet exponentially encouraged the growth of Akkermansia
muciniphila, a bacteria associated with thickened mucosal lining of
the gut, improved gut barrier function, and lean body mass.
Furthermore, benchtop studies indicated that the 3-D structure and
unique properties of Gel-B is required to support the increased
growth of Akkermansia. These data suggest that superabsorbent
hydrogels may offer additional therapeutic mechanisms promoting
metabolic health beyond their space occupying properties.
Gelesis’ superabsorbent hydrogels are inspired by the
composition 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.
The full text of the announcement from Gelesis is as
follows:
Gelesis’ Proprietary Superabsorbent Hydrogel
Induced Beneficial Changes to the Gut Microbiota and Expanded
Akkermansia, a Bacterial Species Associated with Gut Health and
Weight Loss, in New Study
New pre-clinical data presented today at the
World of Microbiome Conference suggest adding superabsorbent
hydrogel to a high-fat “western-like” diet prevents unfavorable
changes in the communities of gut bacteria associated with
diet-induced weight gain
BOSTON, April 29, 2022 – Gelesis (NYSE: GLS), a
consumer-focused biotherapeutics company and the maker of Plenity®,
released today a poster presentation at the World of Microbiome
annual meeting in Vienna. The pre-clinical study showed
administration of one of the company’s proprietary superabsorbent
hydrogels, Gel-B, significantly shifted the composition of the
microbiome to a profile correlated with better metabolic health,
including improved weight and glucose control. Adding Gel-B to a
high-fat diet exponentially encouraged the growth of Akkermansia
muciniphila, a bacteria associated with thickened mucosal lining of
the gut, improved gut barrier function, and lean body mass.
Furthermore, benchtop studies indicated that the 3-D structure and
unique properties of Gel-B is required to support the increased
growth of Akkermansia. These data suggest that superabsorbent
hydrogels may offer additional therapeutic mechanisms promoting
metabolic health beyond their space occupying properties.
“Obesity is a complex disease and recent research has shown that
alterations of the gut microbiome may be one cause. It follows that
interventions used to modify the microbiome could be important
tools for the treatment of obesity,” said Neil Floch, MD, a
bariatric surgeon and expert on obesity treatment at Nuvance Health
in Norwalk, CT. “I look forward to seeing more clinical studies on
this new class of materials and their potential mechanical benefits
on gut health and the microbiome.”
Gelesis’ superabsorbent hydrogels are inspired by the
composition 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.
This new study aimed to define the gut microbiota associated
with observed metabolic improvement and uncover how Gel-B may be
driving compositional changes to these microbiota communities.
After being fed a high fat diet (45% lard) for 12 weeks, the
studied groups of mice were treated with a combination high fat
diet and Gel-B, or a control of high fat diet alone for an
additional 12 weeks. Fecal samples were collected at study weeks
12, 16, and 24. Results showed that mice fed Gel-B treatment in
addition to a high fat diet had gut microbiota changes,
including:
- Restoration of the Bacteroidetes/Firmicutes ratio, which is
often out of balance in patients with obesity
- Increase in Verrucomicrobia driven exclusively by Akkermansia
muciniphila
The increased abundance of Akkermansia muciniphila was confirmed
in benchtop studies, where results indicated that the 3-D structure
of Gel-B was required for this phenomenon. Un-crosslinked modified
cellulose, a linear fiber with a much lower elastic response which
is used as a building block of Gel-B, did not support the growth of
this species.
“We were excited to see that, along with weight loss and changes
in gut permeability, we saw beneficial changes in the gut
microbiota,” said Maria Rescigno, PhD, Group Leader of the Mucosal
Immunology and Microbiota Unit at Humanitas University in Milan,
one of the lead investigators on the study. “Most pronounced was an
increase in Akkermansia muciniphila, which is known to be
associated with metabolic health.”
An interview with study co-authors Alessandra Silvestri, PhD and
Antonio Gil-Gomez, PhD is available at
https://youtu.be/3YnzduqRyq8.
In previous studies, administration of one of these hydrogels,
Gel-B, in addition to a high-fat diet, blunted weight gain,
reversed gut atrophy, improved metabolic parameters, and restored
gut barrier function.
About Gelesis
Gelesis Holdings Inc. (NYSE: GLS) (“Gelesis”) is a
consumer-centered biotherapeutics company and the maker of
Plenity®, 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® 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® is indicated to aid weight management in adults with
excess weight or obesity, a Body Mass Index (BMI) of 25–40 kg/m²,
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:
- 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.
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® 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® 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’s most recent Annual Report on Form 10-K filed
on April 1, 2022, 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, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220429005091/en/
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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