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Gelesis100 pivotal study results in significant weight loss

58% of treated adults lost 5% or more of their weight over six months, and almost twice as many individuals achieved 10% or more weight loss compared to placebo

Gelesis has revealed that a pivotal weight loss study of one of its product candidates, Gelesis10, exceeded one of the two co-primary endpoints with 58% of adults in the Gelesis100 treatment arm achieving clinically meaningful weight loss of 5% or more during the study. The percent of patients who achieved 5% or more weight loss was statistically significant compared to placebo (58% vs. 42%, p=0.0028).

Additionally, almost twice as many adults on Gelesis100 lost 10% or more of their body weight compared to the placebo group (20% vs. 12%, p=0.027). Although the study did not meet the other co-primary endpoint of 3% mean difference from placebo, the Gelesis100-treated adults showed statistically significant weight loss vs. placebo (p=0.0032).

“Based on these results, Gelesis100 could potentially be the treatment we’ve been missing for the patients who need it most. Current interventional approaches to weight loss are often invasive and/or have serious side effects," said Dr Frank L Greenway, a leading expert in the field of weight research and the principal investigator in the GLOW study. “As a physician, knowing that the majority of my patients could achieve clinically meaningful weight loss without some of the safety trade-offs makes me excited about this potential new approach.”

Gelesis100 is a new approach to weight loss that is designed to employ multiple mechanisms of action along the GI tract to promote satiety and induce weight loss. Gelesis100 is non-systemic and administered orally in capsules containing small hydrogel particles, which are made from two naturally-derived ingredients that compose a novel 3D matrix. The novel hydrogel is manufactured through Gelesis’ multi-step, proprietary process and protected by 9 families of patents, several of which have already been allowed or issued in major markets.

Gelesis100 capsules are taken with water prior to a meal, after which the hydrogel particles are released from the capsules in the stomach and rapidly absorb water, hydrating to approximately 100 times their original size. Gelesis100 is designed to mix homogeneously with food and travel through the GI tract, inducing satiety, reducing hunger, and causing weight loss. Once in the large intestine, Gelesis100 releases most of the water, which is reabsorbed by the body. The small gel particles pass through the body without being absorbed and are safely eliminated in the same manner as food.

The Gelesis Loss Of Weight (GLOW) Study was a randomized, double-blind, placebo-controlled, parallel-group study enrolling 436 adults with a BMI≥27 and ≤40, including those with prediabetes or type 2 diabetes. The six-month study compared a 2.25 g dose of Gelesis100, administered twice daily, to placebo and was conducted at 33 sites across the US and several European countries. Both the Gelesis100 and placebo arms also included a hypocaloric diet and daily physical activity. An ongoing six-month extension study will provide additional safety and efficacy results out to one year.

Gelesis100 showed no increased safety risk, no serious adverse events, and a lower dropout rate compared to placebo. Full results will be presented at a scientific conference and will be submitted for publication in a peer-reviewed medical journal. Given the demonstrated weight loss and safety profile, Gelesis plans to discuss filing with regulatory authorities and if they are supportive, plans to file for approval.

“We are pleased with the results of the study, particularly that 6 out of 10 adults on Gelesis100 achieved 5% or more weight loss within six months, and 20% of adults on Gelesis100 reached 10% or more weight loss,” said Dr Hassan M Heshmati, Chief Medical Officer of Gelesis. “Based on this and our other studies, we look forward to sharing the full data package with regulatory authorities and to potentially bringing Gelesis100 to patients.”

“Feedback from physicians and patients has consistently highlighted the attractiveness of this new oral, non-systemic approach to weight loss,” commented David Pass, Chief Operating Officer and Head of Commercial for Gelesis. “We continue to build our commercial capabilities, and we are working to bring Gelesis100 to the millions of people around the world who are struggling with their weight.”

Gelesis100 has been studied in more than 500 patients across five clinical studies throughout the US, Canada, and Europe and has shown weight loss, increased satiety, reduced hunger, and a consistently strong safety profile.

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