Gelesis, a biotechnology company developing first-in-class hydrogel therapeutics to treat obesity and other chronic diseases related to the gastrointestinal (GI) tract, 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.
Plenity represents a new prescription option for millions of adults. More than half of the approximately 150 million adults in the US 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.
Plenity is an oral, non-systemic, superabsorbent hydrogel which has received FDA clearance as an aid in weight management in overweight and obese adults with a BMI of 25–40 kg/m2, when used in conjunction with diet and exercise. It is made by cross-linking two naturally derived building blocks, modified cellulose and citric acid, that create a three-dimensional matrix. Plenity particles rapidly absorb water in the stomach and homogenously mix with ingested foods. Rather than forming one large mass, it creates thousands of small individual gel pieces with the elasticity (firmness) of solid plant-based foods (e.g., vegetables) without caloric value. The Plenity hydrogel mass increases the volume and elasticity of the stomach and small intestine contents and induces a feeling of fullness and satiety. Once it arrives in the large intestine, the hydrogel is partially broken down by enzymes and loses its three-dimensional structure along with most of its absorption capacity. The released water is reabsorbed in the large intestine, and the remaining cellulosic material is expelled in the faeces.
In April 2019, Gelesis received 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. Gelesis is preparing to initiate a targeted US launch of Plenity in the second half of 2019 and anticipates Plenity will be broadly available by prescription in the US in 2020.