BOSTON– Gelesis (NYSE: GLS), a consumer-focused biotherapeutics company and the maker of Plenity®, today presented results from the LIGHT-UP clinical trial for adults with overweight or obesity who have prediabetes or type 2 diabetes and were treated with either GS200 or placebo. Approximately 6 out of 10 adults treated with GS200 achieved clinically meaningful response to treatment (achieving at least 5% body weight loss), losing on average 11% of their body weight (~23 pounds) and an average reduction of 5.5 inches off their waist circumference. Approximately 1 out of 3 GS200-treated adults were “super responders,” losing at least 10% of their body weight and on average losing 13% (~30 pounds), or 7 inches off their waist circumference. The overall incidence of adverse events (AEs) in adults treated with GS200 was similar to the incidence of AEs in the placebo group. The detailed findings were presented at three poster presentations at the European Congress on Obesity 2022.
Anti-obesity medications are prescribed in less than 2% of people with overweight or obesity in the US mainly due to concerns about the safety or tolerability of existing medications. There is a need for orally administered treatments that can induce clinically meaningful weight loss, with no significant increased safety risk, especially in people with type 2 diabetes or prediabetes since they typically face increased challenges losing weight and have higher risk of developing serious comorbidities.
“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,” said Frank L. Greenway, MD, Medical Director and Professor at the Pennington Biomedical Research Center of the Louisiana State University and one of the study’s lead investigators. “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.”
GS200 is an orally administered superabsorbent hydrogel taken by capsule with water 10 minutes before lunch and dinner and is designed to act mechanically in the gastrointestinal tract in order to induce satiety in patients with prediabetes and type 2 diabetes. Participants in LIGHT-UP were also instructed to follow a modestly reduced calorie diet along with moderate-intensity physical activity. In the GS200 group there was clear and early separation between responders and non-responders to treatment, and response to therapy could be predicted as early as 6 weeks of treatment.
“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,” said Harry L. Leider, MD, MBA, FACPE, Chief Medical Officer of Gelesis. “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. Given the highly attractive safety and tolerability profile, GS200 has the potential to become an exciting new therapy, especially among those in the lower spectrum of excess weight who also have prediabetes or type 2 diabetes.”
