PureTech Health announced its founded entity, Gelesis Holdings, presented positive results from the Light-Up clinical trial of GS200 in overweight and obese adults who have prediabetes or type 2 diabetes.
PureTech Health announced that its founded entity, Gelesis Holdings, presented positive results from the Light-Up clinical trial of GS200 in overweight and obese adults who have prediabetes or type 2 diabetes.
About 60% of the adults treated with the drug had a clinically meaningful response, which was defined as losing at least 5% of body weight. However, the actual response was a loss of an average of 11% of their body weight, or about 23 pounds, and an average reduction of 5.5 inches off their waist circumference.
Furthermore, one out of three of the patients receiving the drug were “super responders” who lost at least 10% of their body weight, on average losing 13% or about 30 pounds, or seven inches off their waist circumference. Adverse events were similar to that seen in the placebo group. They presented the findings in three posters at the 2022 European Congress on Obesity.
“There is a very large population of adults with prediabetes and diabetes who have a greater need for weight loss due to higher medical risks and a greater difficulty losing weight,” Dr. Frank L. Greenway, M.D., medical director and professor at the Pennington Biomedical Research Center of Louisiana State University and one of the study’s lead investigators, said in a statement.
Greenway went on to say, “The compelling weight loss data that favors diabetes and prediabetes is unique among weight loss treatments. Its convenient oral administration, and very favorable tolerability make it a potentially important tool to aid clinicians and patients achieve clinically meaningful weight loss.”
The drug is an oral superabsorbent hydrogel capsule taken with water 10 minutes before lunch and dinner. It acts mechanically in the gastrointestinal tract to induce satiety. The patients in the trial were also given instructions to follow a modestly reduced-calorie diet with moderate-intensity physical activity.
They observed what they are calling “a highly binary effect” with a clear difference between responders and non-responders as early as six weeks of treatment. Of the adults who completed the study, 64% who received the drug were responders, compared to 41% of the placebo group. In the group who didn’t fully complete the study, 55% of patients receiving the drug were responders versus 34% in the placebo group. The average body weight loss of the responders was 11% or about 23 pounds, with 5.5 inches lost from their waist circumference. They emphasize patients who received the drug had a 2.8 higher probability compared to placebo to become responders.
As a biotech company, PureTech creates Founded Entities, which are subsidiary companies built around specific programs. It is made up of 27 therapeutics and therapeutic candidates, two of which have been approved in the U.S. and Europe. Gelesis is a consumer-centered biotherapeutics company that has a marketed product for weight management, Plenity. Its pipeline focuses on developing treatments for Type 2 diabetes, non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH) and functional constipation.
Gelesis reported its 2021 financials on March 24. It launched Plenity earlier in this year, and as of March 24, had observed a 3.5-fold growth in new Plenity prescriptions in the first few weeks. The company also raised $105 million from a business combination with Capstar Special Purpose Acquisition Corp. on Jan. 13, 2022, going public on the New York Stock Exchange under the GLS ticker symbol.
Product revenue for the year was $11.2 million, a 313% increase from 2020. The company projects net project revenue for 2022 of $58 million, and a gross profit of $25 to $30 million.
In today’s report, Dr. Harry L. Leider, M.D., Gelesis’ chief medical officer, noted, “There is a real need for tolerable, effective, and affordable therapeutics to aid in weight loss for patients with prediabetes and type 2 diabetes. Approximately 130 million Americans have prediabetes or type 2 diabetes and approximately 80% struggle with excess weight. Importantly, these individuals also have a high risk of heart disease and other serious chronic conditions, related to overweight and obesity, making this one of the biggest public health issues facing our society. These data show that GS200 produces clinically meaningful weight loss for the majority of patients and that it’s possible to identify these responders early in treatment.”
