A novel hydrogel platform technology to treat overweight, obesity and other chronic metabolic diseases, was the subject pf one oral presentation and two poster presentations showcasing notable efficacy data for Plenity (Gelesis 100) at the European and International Congress on Obesity (ECO-ICO 2020).
Plenity is an oral, non-systemic therapeutic cleared by the FDA as an aid for weight management in adults with a BMI25–40, when used in conjunction with diet and exercise. The company also received a CE mark, which enables the marketing of Plenity in Europe. The novel treatment is administered in the form of capsules taken with water before lunch and dinner. 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 hydrogel contributes to a feeling of fullness and induces satiety.
The data presented in the oral presentation are from a subgroup analysis from Gelesis Loss Of Weight (GLOW) Study, a pivotal weight loss study, assessing the safety and efficacy of Plenity in study participants reaching BMI 27.
The GLOW study was a randomised, double-blind, placebo-controlled, parallel-group six-month study that compared a 2.25g dose of Plenity, administered twice daily, to placebo and was conducted at 33 sites across the US and several European countries. Both the active and placebo arms also included a hypocaloric diet and daily physical activity. The study had two predefined co-primary endpoints: at least 35% of patients taking Plenity achieving ≥ 5% weight loss (categorical endpoint) and placebo-adjusted weight loss with a super-superiority margin of 3%.
The mean BMI at baseline for this Plenity-treated subgroup was 29.9+/-1.56. Within this subgroup, adults treated with Plenity, on average, lost 13.5% of their total body weight during the trial with the rate of weight loss tapering as participants approached a healthy BMI. After achieving a BMI of <27, participants continued Plenity treatment for an average of 60 days. The overall safety and tolerability profile of Plenity within this group was no different from placebo.
“Plenity presents both patients and clinicians with the opportunity for early intervention progression,” said Dr Ken Fujioka, endocrinology researcher at Scripps Clinic and scientific advisor to Gelesis. “Based on the weight loss achieved in patients lower in the BMI spectrum, this is a scientifically-validated option for patients looking to lose as little as 10-15 pounds, or more.”
Plenity is currently available in the U.S. in limited release with a full launch in 2021.