Gelesis announced that the Food and Drug Administration (FDA) has cleared Plenity (Gelesis100) to aid in weight management for overweight and obese adults, in conjunction with diet and exercise.
Available in capsule form, Plenity, a non-systemic, superabsorbent hydrogel, is intended for use in adults with a body mass index (BMI) of 25–40kg/m2 and is taken orally before lunch and dinner. It is the first prescription product to be approved for use in adults with a BMI as low as 25kg/m2, with or without comorbidities such as hypertension, type 2 diabetes, or dyslipidemia, according to the Company.
The capsules consist of a 3-D hydrogel matrix made by cross-linking cellulose and citric acid. Once ingested, the capsules release non-aggregating particles that absorb water in the stomach, creating individual gel pieces with the elasticity of plant-based foods but without the calories. The gel pieces expand and mix with the contents in the stomach and small intestine, making the patient feel fuller. The particles pass through the digestive system, break down in the colon, and are eliminated with a bowel movement.
Plenity and its prototypes were evaluated in 5 clinical studies where it consistently showed efficacy and favorable safety and tolerability profiles. In the GLOW (Gelesis Loss of Weight) study (N=436), adults with overweight or obesity were evaluated for change in body weight after 6 months of treatment.
The data showed 59% of Plenity-treated adults achieved ≥5% weight loss (categorical endpoint) compared with 42% in the placebo group; treatment was proven to be superior to placebo (-6.4% vs -4.4%; P =.0007). In addition, the proportion of adults who were super-responders (defined as ≥10% weight loss) was higher in the Plenity intent-to-treat population vs the placebo group (27% vs 15%); super-responders achieved about 14% weight loss (~30lbs). Moreover, patients who received Plenity were twice as likely to achieve ≥5% (adjusted odds ratio [OR], 2.0; P =.0008) and ≥10% (OR: 2.1, P =.0107) weight loss vs placebo.
Gastrointestinal disorders, infections/infestations, and musculoskeletal/connective tissue disorders were the most common treatment-related adverse events associated with Plenity.
“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,” stated Yishai Zohar, founder and chief executive officer of Gelesis.
Initial launch of Plenity is anticipated for the second half of this year with a full commercial launch in 2020. Plenity will be supplied in double blister packs that provide the 2 daily doses; each dose includes 3 capsules provided in a single blister pack.
For more information visit MyPlenity.com.