Gelesis’ six-month study of weight loss in
adults with overweight or obesity who have prediabetes or type 2
diabetes met both of its primary endpoints: the proportion of
participants who achieved at least 5% body weight loss (i.e.,
“Categorical”) and the change in body weight after six months of
therapy
GS200 demonstrated a highly favorable
Categorial weight loss response and tolerability in a population
that often struggles to lose weight and is at high risk for
obesity-related complications; the overall incidence of adverse
events (AEs) in adults treated with GS200 was similar to the
placebo group
~6 out of 10 GS200-treated adults achieved at
least 5% weight loss (“Responders”), losing on average 11% (~23
pounds), or 5.5 inches off their waist circumference in only 24
weeks
~1 out of 3 GS200-treated adults were “super
responders,” losing at least 10% of their body weight and on
average losing 13% (~30 pounds), or 7 inches off their waist
circumference in only 24 weeks
Gelesis (NYSE: GLS), a consumer-focused biotherapeutics company
and the maker of Plenity®, today presented results from the
LIGHT-UP clinical trial for adults with overweight or obesity who
have prediabetes or type 2 diabetes and were treated with either
GS200 or placebo. Approximately 6 out of 10 adults treated with
GS200 achieved clinically meaningful response to treatment
(achieving at least 5% body weight loss), losing on average 11% of
their body weight (~23 pounds) and an average reduction of 5.5
inches off their waist circumference. Approximately 1 out of 3
GS200-treated adults were “super responders,” losing at least 10%
of their body weight and on average losing 13% (~30 pounds), or 7
inches off their waist circumference. The overall incidence of
adverse events (AEs) in adults treated with GS200 was similar to
the incidence of AEs in the placebo group. The detailed findings
were presented at three poster presentations at the European
Congress on Obesity 2022.
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There is a need for orally administered
treatments that can induce clinically meaningful weight loss, with
no significant increased safety risk, especially in people with
type 2 diabetes or prediabetes since they typically face increased
challenges losing weight and have higher risk of developing serious
comorbidities. (Graphic: Business Wire)
Anti-obesity medications are prescribed in less than 2% of
people with overweight or obesity in the US mainly due to concerns
about the safety or tolerability of existing medications. There is
a need for orally administered treatments that can induce
clinically meaningful weight loss, with no significant increased
safety risk, especially in people with type 2 diabetes or
prediabetes since they typically face increased challenges losing
weight and have higher risk of developing serious
comorbidities.
“There is a very large population of adults with prediabetes and
diabetes who have a greater need for weight loss due to higher
medical risks and a greater difficulty losing weight,” said Frank
L. Greenway, MD, Medical Director and Professor at the Pennington
Biomedical Research Center of the Louisiana State University and
one of the study’s lead investigators. “The compelling weight loss
data that favors diabetes and prediabetes is unique among weight
loss treatments. Its convenient oral administration, and very
favorable tolerability make it a potentially important tool to aid
clinicians and patients achieve clinically meaningful weight
loss.”
GS200 is an orally administered superabsorbent hydrogel taken by
capsule with water 10 minutes before lunch and dinner and is
designed to act mechanically in the gastrointestinal tract in order
to induce satiety in patients with prediabetes and type 2 diabetes.
Participants in LIGHT-UP were also instructed to follow a modestly
reduced calorie diet along with moderate-intensity physical
activity. In the GS200 group there was clear and early separation
between responders and non-responders to treatment, and response to
therapy could be predicted as early as 6 weeks of treatment.
“There is a real need for tolerable, effective, and affordable
therapeutics to aid in weight loss for patients with prediabetes
and type 2 diabetes. Approximately 130 million Americans have
prediabetes or type 2 diabetes and approximately 80% struggle with
excess weight. Importantly, these individuals also have a high risk
of heart disease and other serious chronic conditions, related to
overweight and obesity, making this one of the biggest public
health issues facing our society,” said Harry L. Leider, MD, MBA,
FACPE, Chief Medical Officer of Gelesis. “These data show that
GS200 produces clinically meaningful weight loss for the majority
of patients and that it’s possible to identify these responders
early in treatment. Given the highly attractive safety and
tolerability profile, GS200 has the potential to become an exciting
new therapy, especially among those in the lower spectrum of excess
weight who also have prediabetes or type 2 diabetes.”
About Gelesis’ LIGHT-UP Clinical Study
The multicenter, double-blind, randomized, placebo-controlled
study enrolled 254 subjects and was designed to assess the change
in body weight in adults with overweight or obesity, who have
prediabetes or diabetes, after six months of treatment with a new
oral superabsorbent hydrogel (GS200) or placebo. The study met both
of its primary endpoints: the proportion of participants who
achieved at least 5% body weight loss and the change in body weight
after six months of therapy.
A highly binary effect was observed with the GS200 treatment
group, with a clear separation between responders and
non-responders as early as after 6 weeks of treatment. Among the
adults who completed the study protocol requirements (PP
population), 64% of GS200-treated adults were Responders vs. 41% in
the placebo group (p=0.001). In the analysis which also included
data from the participants who didn’t fully complete the study
(ITT-MI), 55% of GS200-treated adults were Responders vs. 34% in
the placebo group (p=0.0004). The average body weight loss of the
Responders was 11% (approximately 23 pounds) and their waist
circumference was reduced by 5.5 inches on average. Importantly,
Gelesis treated individuals had 2.8 higher odds compared with
placebo to become Responders (adjusted odds ratio = 2.83,
P=0.0004), achieving the first primary endpoint of the study.
With respect to average total weight loss, the complete GS200
treatment group (including both Responders and Non-Responders)
demonstrated superiority over placebo after 6 months of treatment
(body weight loss of 7.1% vs. 4.6%, P=0.0029 in the PP population
or 6.9% vs. 4.3%, P=0.0011 in the ITT population), thereby
achieving the second primary endpoint.
GS200 demonstrated a highly favorable safety and tolerability
profile as the overall incidence of adverse events (AEs) in adults
treated with GSP200 was similar to the incidence of AEs in the
placebo group.
About GS200
GS200 is a non-systemic, superabsorbent hydrogel in development
for the treatment of obesity and for glycemic control. It is made
by utilizing the same proprietary hydrogel platform technology
Gelesis developed for its previously FDA cleared product, GS100
(Plenity®). Like GS100, GS200 is made from naturally derived
cross-linked modified cellulose, however with a higher molecular
weight. GS200 was designed to hydrate faster and create a higher
elastic response in the GI tract compared with GS100. Its
properties were optimized in preclinical studies based on its
effect on the gut barrier and microbiome, as well as reduced
insulin resistance and weight loss. Like GS100, GS200 is a
three-dimensional matrix of cellulose, capable of absorbing a much
larger volume of water in the stomach and small intestines. Orally
administered in capsules with water before meals, GS200 particles
rapidly absorb water in the stomach and homogenously mix with
ingested food. This creates thousands of small individual gel
pieces with composition (cellulose and water) and elasticity
(firmness) similar to solid ingested raw vegetables, without any
caloric value. Once it arrives in the large intestine, the hydrogel
is partially broken down by naturally occurring 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 expelled naturally. GS200
is considered a medical device because it achieves its primary
intended purpose through mechanical modes of action consistent with
mechanobiology constructs, and it is not absorbed through the
gastrointestinal tract. GS200 received a Non-Significant Risk (NSR)
determination by the FDA for the LIGHT-UP study.
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 commercially available
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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Media & Investor
Relations Katie Sullivan ksullivan@gelesis.com
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