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Home>Gelesis100 Achieves Significant Weight Loss with Excellent Safety Profile in Pivotal Study

Gelesis100 Achieves Significant Weight Loss with Excellent Safety Profile in Pivotal Study

Gelesis100 Achieves Significant Weight Loss with Excellent Safety Profile in Pivotal Study

09/25/2017

Gelesis100 Achieves Significant Weight Loss with Excellent Safety Profile in Pivotal Study

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

Study exceeded one of two co-primary endpoints and Company plans to move forward with submission for regulatory approvals

Gelesis, a biotechnology company developing first-in-class therapies to treat chronic diseases related to the gastrointestinal (GI) pathway, today announced topline results from a pivotal weight loss study of one of its product candidates, Gelesis100. The study 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). 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.

“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 Frank L. Greenway, MD, 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.”

The Gelesis Loss Of Weight (GLOW) Study was a randomized, double-blind, placebo-controlled, parallel-group study enrolling 436 adults with a body mass index (BMI) ≥ 27 and ≤ 40 kg/m2, including those with prediabetes or type 2 diabetes. The 6-month study compared a 2.25 g dose of Gelesis100, administered twice daily, to placebo and was conducted at 33 sites across the United States and several European countries. Both the Gelesis100 and placebo arms also included a hypocaloric diet and daily physical activity. An ongoing 6-month extension study will provide additional safety and efficacy results out to one year.

“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 6 months, and 20% of adults on Gelesis100 reached 10% or more weight loss,” said Hassan M. Heshmati, MD, 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, PharmD, 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.”

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