Gelesis, a biotechnology company developing first-in-class hydrogel therapeutics to treat obesity and other chronic diseases related to the gastrointestinal (GI) tract, today announced that the United States Food and Drug Administration (FDA) has cleared the Company’s lead product candidate, PLENITY™ (Gelesis100), as an aid in weight management in adults with a Body Mass Index (BMI) of 25–40 kg/m2, when used in conjunction with diet and exercise. A BMI of 25 kg/m2 and over is the accepted definition of overweight, and a BMI of 30 kg/m2 and above commonly defines obesity.
“Given the complexity of the disease of obesity and the need for expanded treatment options, the Obesity Action Coalition is encouraged to see continued innovation in safe and effective chronic weight management options. We welcome PLENITY’s addition as a treatment option for people affected by obesity”
PLENITY represents a new prescription option for millions of adults. More than half of the approximately 150 million adults in the U.S. with a BMI ranging from 25 kg/m2 to 40 kg/m2 are classified as overweight (BMI 25-30 kg/m2). Until now, many of them have not had any prescription treatment options. The safety and efficacy profile of PLENITY makes it well-suited for these individuals. It is the only prescription weight management product to be cleared for use by overweight adults with a BMI as low as 25 kg/m2, with and also without comorbidities such as hypertension, type 2 diabetes or dyslipidemia. There is no restriction on how long PLENITY can be used to assist in weight management.
“This FDA clearance is a major milestone for the Gelesis team and our technology, and we are thrilled to be able to bring this new prescription product to the millions of people looking for a safe, validated and convenient treatment option to manage their weight without surgery or stimulants,” said Yishai Zohar, founder and chief executive officer of Gelesis. “With PLENITY, Gelesis is introducing a completely new approach with a unique mechanism of action to aid in weight management, with efficacy and safety supported by positive data from large clinical studies.”
PLENITY is administered in the form of capsules taken with water before lunch and dinner. PLENITY is made by cross-linking two naturally-derived building blocks – cellulose and citric acid – to create a three-dimensional hydrogel matrix. The capsules release thousands of non-aggregating particles that rapidly absorb water in the stomach, creating small individual gel pieces with the elasticity (firmness) of plant-based foods (e.g., vegetables) without caloric value. The gel pieces increase the volume and elasticity of the stomach and small intestine contents, contributing to a feeling of fullness and inducing weight loss. This novel, non-stimulant and non-systemic treatment has been shown in clinical studies to be effective, safe and well-tolerated.
In clinical studies, PLENITY demonstrated a unique combination of effectiveness combined with a highly favorable safety and tolerability profile. Data from the PLENITY pivotal study, Gelesis Loss Of Weight (GLOW), were published recently in the scientific journal Obesity and that paper was selected as an Editor’s Choice manuscript. Pivotal data from the GLOW study were also presented in three posters, one receiving a special recognition award, and an oral presentation at the Obesity Society Annual Meeting 2018.
“Given the complexity of the disease of obesity and the need for expanded treatment options, the Obesity Action Coalition is encouraged to see continued innovation in safe and effective chronic weight management options. We welcome PLENITY’s addition as a treatment option for people affected by obesity,” said Joe Nadglowski, president and chief executive officer of the Obesity Action Coalition.