The 25-week weight loss study which achieved
its previously reported primary endpoints also examined the effects
of GS200 on insulin resistance
Gelesis Holdings Inc. (NYSE: GLS) (“Gelesis” or the “Company”)
the maker of Plenity for weight management, today released a poster
presentation at the International Congress of Endocrinology in
Singapore. The LIGHT-UP study evaluated the safety and efficacy of
GS200, an investigational oral hydrogel, which was designed to
emulate the properties of ingested raw vegetables, with slightly
different mechanical properties compared to Plenity (GS100).
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GS200 hydrogel in the gastrointestinal
tract. (Graphic: Business Wire)
The LIGHT-UP study was conducted over 25 weeks in 254
participants with prediabetes or type 2 diabetes and a BMI of 27-40
kg/m2. It met its primary endpoints and GS200 reported 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. One out of three 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 25 weeks.
“In previous studies we observed better weight loss response for
individuals with prediabetes. In this study we wanted to understand
if we could replicate this intriguing finding also with people who
have type 2 diabetes, since typically weight loss is even more
challenging for them” said Frank L. Greenway, MD, Medical Director
and Professor at the Pennington Biomedical Research Center,
Louisiana State University and one of the study’s lead
investigators. “These findings could help us to understand the
reason why the hydrogel therapy works better for people with
elevated insulin resistance, which is important given the
heterogeneity of the mechanisms driving weight gain and
obesity.”
The study also investigated meal-time insulin release in people
with prediabetes using a two-hour oral glucose tolerance test.
Participants with prediabetes treated with GS200 had significantly
less total mealtime insulin release, compared to placebo, the mean
difference was -22.0%, P=0.04. The peak level of mealtime insulin
was also significantly lower for people that used GS200 when
compared to placebo with a mean difference of 47.3μU/mL,
P=0.03.
“These reductions in mealtime insulin release were statistically
significant even after controlling for changes in weight loss
between GS200 and placebo, indicating that the observed
improvements are independent of weight loss, suggesting additional
mechanisms involved in the metabolic effects of the oral hydrogel
technology,” said Elaine Chiquette, Gelesis Chief Scientific
Officer. “These are exciting results, and we continue to
investigate how GS200 affects insulin response and weight loss in
people with prediabetes and type 2 diabetes.”
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.
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 25 weeks 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 25 weeks 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.
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 Gelesis’ or its management team’s
expectations, hopes, beliefs, intentions or strategies regarding
the future, including those relating to Gelesis’ expected operating
and financial performance and market opportunities. 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 Gelesis’ 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 ability of Gelesis to raise financing, if and when needed; (ii)
the ability of Gelesis to continue as a going concern; (iii)
Gelesis’ ability to achieve and maintain widespread market
acceptance of Plenity; (iv) the impact of current and future
applicable laws and regulations and Gelesis’ ability to comply with
such laws and regulations; (v) Gelesis’ ability to produce adequate
supply of Plenity, including Gelesis’ ability to continue to invest
in manufacturing capacity and to build additional manufacturing
sites; (vi) the development of the telehealth market and
regulations related to remote healthcare; (vii) global economic,
political and social conditions and uncertainties in the markets
that Gelesis serves, including risks and uncertainties caused by
the COVID-19 pandemic or other natural or man-made disasters;
(viii) Gelesis' ability to enter into strategic collaborations, to
acquire businesses or products or form strategic alliances and to
realize the benefits of such collaborations, acquisitions and
alliances; (ix) the level of demand, and willingness of potential
members to pay out-of-pocket for, Plenity; (x) the ability of
Gelesis to enforce its intellectual property rights and proprietary
technology ; (xi) the risk that a third-party’s activities,
including with respect to third parties that Gelesis has granted
outlicenses to or granted limited exclusive or non-exclusive
commercial rights, may overlap or interfere with the
commercialization of Plenity; (xii) Gelesis’ ability to
successfully develop and expand its operations and manufacturing
and to effectively manage such growth; (xiii) Gelesis’ business
partners' ability to successfully launch and commercialize Plenity
in certain key markets; (xiv) risk relating to the loss of Gelesis’
suppliers or distributors, or their inability to provide adequate
supply of materials or distribution; (xv) the risk that Gelesis’
business partners may experience significant disruptions in their
operations; (xvi) Gelesis’ ability to retain its senior executive
officers and to attract and keep senior management and key
scientific and commercial personnel; (xvii) Gelesis’ ability to
identify and discover additional product candidates and to obtain
and maintain regulatory approval for such candidates; (xviii) risks
related to potential product liability exposure for Plenity or
other future product candidates; (xix) risks related to adverse
publicity in the weight management industry, changes in the
perception of Gelesis’ brands, and the impact of negative
information or inaccurate information about Gelesis on social
media; (xx) Gelesis’ ability to enhance its brand recognition,
increase distribution of Plenity and generate product sales and
reduce operating losses going forward; (xxi) the impact of risks
associated with economic, financial, political, environmental and
social matters and conditions on Gelesis’ supply chain, its
manufacturing operations and other aspects of its business; (xxii)
Gelesis’ ability to accurately forecast revenue and appropriately
monitor its associated expenses in the future; (xxiii) Gelesis’
ability to compete against other weight management and wellness
industry participants or other more effective or more favorably
perceived weight management methods, including pharmaceuticals,
devices and surgical procedures; (xxiv) foreign currency
fluctuations and inflation; (xxv) the risk that Gelesis fails to
maintain adequate operational and financial resources or to raise
additional capital or generate sufficient cash flows; (xxvi)
Gelesis’ ability to successfully protect against security breaches
and other disruptions to its information technology structure;
(xxvii) the ability of Gelesis to maintain its listing on the New
York Stock Exchange; (xxviii) failure to realize the anticipated
benefits of the business combination; and (xxix) 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.
Source: Gelesis Holdings, Inc.
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