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
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.
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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. (Graphic: Business Wire)
“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,
and 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220429005102/en/
Media & Investor
Relations Katie Sullivan ksullivan@gelesis.com
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