PureTech subsidiary Gelesis today touted results from a pivotal weight-loss study of its obesity drug, Gelesis100.
The study met one of its two primary endpoints, with 58% of adults in the treatment arm experiencing clinically-meaningful weight loss of 5% or more.
Nearly twice as many adults lost 10% or more of the body weight in the treatment group compared to those taking a placebo, the company reported. However, the study did not meet its second primary endpoint – a 3% average difference from the placebo.
Regardless, the company said it plans to discuss filing for regulatory approval of its obesity treatment, which is a capsule containing small hydrogel particles.
“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,” principal investigator Dr. Frank Greenway said in prepared remarks. “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 drug’s hydrogel particles are designed to mix with food in the body and swell to almost 100 times their original size once in the stomach. After the particles land in the large intestine, they release most of their water, which is then reabsorbed.
“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,” Gelesis’ CMO Dr. Hassan Heshmati added. “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,” COO & head of Gelesis’ commercial business David Pass said. “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.”
See the best minds in medtech live at DeviceTalks Boston on Oct. 2.
