Gelesis is a consumer-centered biotherapeutics company with focus on the developing a novel hydrogel platform technology to treat overweight, obesity, and chronic diseases related to the GI pathway. Gelesis received the U.S. FDA clearance for its lead product candidate PLENITY, as an aid for weight management in overweight and obese adults with a Body Mass Index (BMI) of 25-40 kg/m², when used in conjunction with diet and exercise. PLENITY was also granted a CE mark. Additionally, Gelesis’s portfolio includes potential therapies in development for patients with Type 2 Diabetes, Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH), and Functional Constipation. Gelesis is a publicly traded company listed on the New York Stock Exchange (NYSE:GLS). For more information about Gelesis, please visit www.gelesis.com.
PLENITY, developed based on the proprietary hydrogel technology platform of the Group’s partner Gelesis, is an orally-administered, non-systemic, non-stimulant, safe and effective weight management product made from two naturally derived materials, cellulose and citric acid. It is administered in the form of capsules taken with water before a meal. The capsules release thousands of particles that rapidly absorb water in the stomach, creating small individual gel pieces with the elasticity and firmness of plant-based foods (e.g., vegetables) without caloric value. The gel contributes to a feeling of fullness and induces satiety, which can help with weight loss. The product has been approved for marketing in the U.S.
The U.S. FDA approval was based on data from a randomized, double-blind, placebo-controlled pivotal clinical trial conducted on 436 patients with overweight or obesity (BMI of 27-40 kg/m2). After six months of treatment, nearly 60% patients achieved at least 5% weight loss (an average of 10% weight loss, or 10 kg) and 26% achieved at least 10% (an average of 14% weight loss, or 13 kg). Meanwhile, PLENITY demonstrated a highly favorable safety profile: no difference in the overall incidence of adverse events compared with placebo.
In China, overweight and obesity accounted for 23% and 5% of the adult population respectively in 2015. Currently, the commonly used weight loss and weight maintenance medicines have different degrees of adverse reactions; whilst, most products in the consumer healthcare field have not been fully validated by evidence-based medicine in terms of effectiveness and safety. The introduction of PLENITY would meet the market demand and provide patients with an effective and safe treatment option.
