Gelesis Secures $30 Million to Support Potential Approval of Weight Loss Drug
Boston-based Gelesis, an affiliate of PureTech Health, snagged $30 million to support potential manufacturing and commercialization of its anti-obesity drug, Gelesis100. The company plans to file for approval in the United States and Europe this year.
David Pass, chief operating officer and head of commercial at Gelesis, said if approved by the U.S. Food and Drug Administration Gelesis100 would be the “first and only oral prescription of its kind” to work in the gastrointestinal system to help people achieve “clinically meaningful weight loss.” Pass said the company looks forward to taking its data to the FDA and European Medicines Agency this year.
Pass touted the efficacy of Gelesis100 and how trial subjects reportedly felt about the oral medication.
“In quantitative research evaluating the pivotal study results with over 600 people struggling to manage their weight, more than 70 percent found Gelesis100 extremely or very appealing based on its clinically proven efficacy and strong safety profile, and over 90 percent of these people were likely to ask their doctor for the product. Additionally, of over 200 clinicians polled, 79 percent of obesity specialists and 63 percent of primary care physicians stated that they were extremely or very likely to prescribe the product if asked,” Pass said.
While that sounds good, Gelesis’ trial data was a bit mixed. In September 2017 Gelesis unveiled data from a study that showed patients lost significantly more weight on Gelesis100 than on placebo. Gelesis said 58 percent of adults who took Gelesis100 during the trial lost 5 percent or more of their weight over a six month period. Gelesis said almost twice as many individuals on the Gelesis100 arm achieved a 10 percent weight loss compared to placebo, 20 percent to 12 percent, according to the released data.
While those weight loss achievements are pretty impressive, Gelesis conceded that the trial only hit one of its two primary endpoints. The trial failed to show a 3 percent mean difference between Gelesis100 and placebo. That failure could hinder potential FDA approval.
Gelesis100 capsules include hydrogel particles. After ingestion, the hydrogel particles absorb water that the pill was taken with and expand to about 100 times their original size. That helps reduce hunger and facilitate weight loss. In the large intestine, the hydrogel particles release the water they absorbed and then pass from the body.
In addition to supporting potential manufacturing and commercialization of Gelesis100, the company said the $30 million in financing will be used to advance its other product candidates for gastrointestinal disorders that include type 2 diabetes and non-alcoholic steatohepatitis/non-alcoholic fatty liver disease (NASH/NAFLD). The financing will certainly be used to continue development of Gelesis200, which will be used for both weight loss and glycemic control in patients with type 2 diabetes and prediabetes.