Waist to Height Ratio, known to be correlated with insulin
resistance & metabolic syndrome, was a predictor of weight loss
response in the study based on a post-hoc analysis
As previously reported, the LIGHT-UP study met its primary
endpoint with 6 out of 10 responding to the treatment, achieving an
average of 11% weight loss and 5.6 inches reduction of their waist
within only 25 weeks
Gelesis Holdings Inc. (NYSE: GLS) (“Gelesis” or the “Company”)
the maker of Plenity for weight management, today announced Dr.
Frank Greenway will give an oral presentation at Obesity Week in
San Diego, on Wednesday, November 2 at 4:00pm PDT.
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Frank L. Greenway, MD, Medical Director and Professor at the
Pennington Biomedical Research Center, Louisiana State University
and the principal investigator of the LIGHT-UP study, will present
data supporting Waist to Height Ratio as a potential biomarker to
help predict weight loss response with GS200 treatment in people
with prediabetes or type 2 diabetes.
Considering the previously reported findings from the LIGHT-UP
study, the significant improvement in fasting insulin and
postprandial insulin response, as well as the notable reduction in
waist circumference (secondary endpoints), a post hoc analysis was
conducted to explore whether abdominal fat affects the level of
weight loss response with the novel hydrogel treatment. Waist to
Height Ratio was used for this analysis as it represents a simple
metric for body shape and potential abdominal fat, known to be
associated with insulin resistance & metabolic syndrome.
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 weight loss in patients with prediabetes and type 2
diabetes.
“Paradoxically, the subgroup with a higher ratio, a marker of
insulin resistance, achieved a better response to GS200 reporting
8.1% weight loss at 6 months,” said Dr. Greenway. “The ratio can be
a simple tool to help clinicians select patients where GS200 work
best for them. The causes and mechanisms to explain this
preferential response continue to be investigated. Growing evidence
is emerging on the interaction between gut wall permeability, gut
microbiota shifts and metabolic health, we need more studies to
understand whether gut mechanisms could explain these intriguing
findings with GS200.”
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.
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.
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.
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