boston–(business wire)–Gelesis Holdings Inc. (NYSE: GLS) (“Gelesis” or the “Company”), the makers of Plenity for weight management, today announced Dr. Frank Greenway at Obesity Week in San Diego on Wednesday. He announced that he would give an oral presentation. , November 2 at 4:00 PM PDT.
Frank L. Greenway, MD, medical director and professor at the Pennington Center for Biomedical Research at Louisiana State University and principal investigator of the LIGHT-UP study, identified West as a potential biomarker to help predict weight loss response. We present data to support the ratio of height to height. His GS200 treatment in pre-diabetic or type 2 diabetic patients.
Given the previously reported results of the LIGHT-UP study, significant improvements in fasting and postprandial insulin responses, and a significant reduction in waist circumference (secondary endpoint), the impact of abdominal fat on body A post hoc analysis was performed to investigate whether Level of weight loss response with new hydrogel treatments. Waist-to-height ratio was used for this analysis to represent a simple metric of body type and potential abdominal fat known to be associated with insulin resistance and metabolic syndrome.
GS200 is an orally administered superabsorbent hydrogel taken in capsule form with water 10 minutes before lunch and dinner and acts mechanically in the gastrointestinal tract to induce weight loss in prediabetic and type 2 diabetic patients. It is designed to
“Paradoxically, the subgroup with a higher percentage of markers of insulin resistance responded better to GS200, reporting 8.1% weight loss at 6 months,” said Dr. Greenway. . “This ratio could be a simple tool to help clinicians select patients for whom GS200 works best. The causes and mechanisms that explain this preferential response continue to be investigated.” There is growing evidence for the interplay between intestinal wall permeability, altered gut microbiota, and metabolic health.To understand whether intestinal mechanisms could explain these intriguing findings in GS200, We need more research.”
About Geresis
Gelesis Holdings Inc. (NYSE: GLS) (“Gelesis”) is a consumer-focused biopharmaceutical company and maker of the nature-inspired Plenity®, FDA-cleared to aid in weight management. increase. Our first non-systemic superabsorbent hydrogel is made entirely from naturally derived building blocks. Inspired by the composition and mechanical properties of raw vegetables, it is taken in capsules and acts locally on the digestive system, leaving people feeling satisfied with smaller amounts. Our portfolio includes Plenity® and potential therapies in development for patients with type 2 diabetes, nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH), and functional constipation is included. For more information, visit gelesis.com or contact us on Twitter @GelesisInc.
Plenity® has been shown to aid weight management in overweight or obese adults with a body mass index (BMI) between 25 and 40 kg/m² when used in conjunction with diet and exercise.
Important safety information about Plenity
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Do not take Plenity if you are pregnant or if you are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin, or titanium dioxide.
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To avoid affecting drug absorption:
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For all medicines that should be taken with food, start with food before taking.
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For all medicines that should be taken without food (on an empty stomach), continue taking them on an empty stomach or as recommended by your doctor.
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The overall incidence of side effects with Plenity did not differ from placebo. The most common side effects were diarrhea, bloating, infrequent bowel movements, and flatulence.
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If you have any problems, call your doctor immediately. If you have a severe allergic reaction, severe stomach pain, or severe diarrhea, stop using Plenity until you can consult your doctor.
Receive only. For the safe and proper use of Plenity or any other information, please consult a healthcare professional, read the patient instructions, or call 1-844-PLENITY.
About the Gelesis LIGHT-UP Clinical Trial
A multicenter, double-blind, randomized, placebo-controlled study enrolled 254 subjects to measure weight change in overweight or obese adults with prediabetes or diabetes with a novel oral superabsorbent hydrogel. It was designed to be evaluated after 25 weeks of treatment with (GS200) or placebo. The study met both primary endpoints. Percentage of participants achieving at least 5% weight loss and weight change after 6 months of treatment.
A high degree of binary effect was observed in the GS200 treatment group, clearly separating responders and non-responders as early as after 6 weeks of treatment. Among adults who completed study protocol requirements (PP population), 64% of his GS200-treated adults were responders compared to 41% of him in the placebo group (p = 0.001) . In an analysis that also included data from participants who did not complete the study (ITT-MI), 55% of adults treated with GS200 were responders compared to 34% in the placebo group ( p=0.0004). Responders had an average weight loss of 11% (approximately 23 pounds) and an average waist circumference loss of 5.5 inches. Importantly, the Gelesis-treated individual had a 2.8 higher probability of becoming a responder compared to placebo (adjusted odds ratio = 2.83, P = 0.0004), meeting the study’s first primary endpoint .
In terms of mean total weight loss, the full GS200 treatment group (including both responders and non-responders) showed superiority to placebo after 25 weeks of treatment (7.1% vs. 4.6% weight loss, PP P = 0.0029) or 6.9% vs 4.3% in the ITT population, P=0.0011) in the ITT population, thereby achieving the second primary endpoint.
GS200 had a very good safety and tolerability profile, as the overall incidence of adverse events (AEs) in adults treated with GSP200 was similar to the incidence of adverse events (AEs) in the placebo group. showed a profile.
Forward-Looking Statements
Certain statements, estimates, goals and projections in this press release may constitute “forward-looking statements” within the meaning of federal securities laws. “predict”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “could”, “could”, Expressions such as “plan”, “could”, “could”, “predict”, “predict”, “should”, “strive”, “would” We may identify forward-looking statements, but the absence of these words does not mean that the statements are not forward-looking. Forward-looking statements are predictions, forecasts 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 the future expectations, hopes, beliefs, intentions or strategies of Gelesis or its management. This also includes those related to Gelesis’ anticipated operating results, financial performance and market opportunities. In addition, statements that refer to projections, projections or other characterizations of future events or circumstances, including underlying assumptions, are forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to place undue reliance on forward-looking statements. Gelesis undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise. Gelesis does not warrant that the expectations set forth in this press release will be achieved. Actual future results, performance or events may differ materially from those set forth herein due to various risks and uncertainties, some of which are beyond the control of Geresis, and other factors. there is. Factors that may affect future results and performance include, but are not limited to: (ii) Geresis’ ability to continue as a going concern; (iii) his Gelesis ability to achieve and maintain broad market acceptance of Plenity; (iv) the impact of current and future applicable laws and regulations and Geresis’ ability to comply with such laws and regulations; (v) Geresis’ ability to generate a sufficient supply of Plenity, including Geresis’ ability to continue to invest in manufacturing capacity and build additional manufacturing sites; (vi) the development of the telemedicine market and regulations related to telemedicine; (vii) global economic, political and social conditions and uncertainties in the markets Gelesis serves, including risks and uncertainties caused by the COVID-19 pandemic or other natural or man-made disasters; (viii) strategic alliances, business or product acquisitions, or formation of strategic alliances, and Geresis’ ability to realize the benefits of such alliances, acquisitions, or partnerships; (ix) the level of demand for Plenity and willingness of potential members to pay out-of-pocket; (x) Geresis’ ability to enforce its intellectual property rights and proprietary technology; (xi) any third party activity (including with respect to third parties to whom Gelesis has outlicensed or granted limited exclusive or non-exclusive commercial rights) overlaps with Plenity’s commercialization; or risks that may interfere. (xii) Geresis’ ability to successfully develop and expand its operations and manufacturing and to manage such growth effectively; (xiii) the ability of Geresis’ business partners to successfully launch and commercialize her Plenity in certain key markets; (xiv) risks associated with the loss of Gelesis’ suppliers or distributors or their inability to provide an adequate supply of materials or distribution; (xv) the risk that Gelesis’ business partners may experience material disruption of their operations; (xvi) Geresis’ ability to retain senior executives and attract and retain senior management and key scientific and commercial personnel; (xvii) her Gelesis’ ability to identify and discover additional product candidates and to obtain and maintain regulatory approval of such candidates; (xviii) risks associated with potential product liability for Plenity or other future product candidates; (xix) risks associated with adverse publicity in the weight management industry, changes in perceptions of the Gelesis brand, and the impact of negative or inaccurate information about her Gelesis on social media; (xx) Gelesis’ ability to increase brand awareness, increase distribution of Plenity, generate product sales and reduce future operating losses; (xxi) the impact of risks associated with economic, financial, political, environmental and social issues and conditions on Gelesis’ supply his chain, manufacturing operations and other aspects of its business; (xxii) Geresis’ ability to accurately forecast revenues and appropriately monitor future related costs; (xxiii) Geresis’ ability to compete with 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 exchange fluctuations and inflation; (xxv) the risk that Gelesis will be unable to maintain adequate operational and financial resources, raise additional capital or generate sufficient cash flows; (xxvi) Gelesis’ ability to successfully protect against security breaches and other disruptions of information technology structures; (xxvii) Geresis’ ability to maintain its listing on the New York Stock Exchange; (xxviii) failure to realize the anticipated benefits of the business combination; (xxix) other important factors described in the “Risk Factors” section of Geresis’ most recent annual report on Form 10-K and in other filings by Geresis with the Securities and Exchange Commission; These filings address other important risks and uncertainties that could cause actual results or events to differ materially from those contained in the forward-looking statements.
