Gelesis Submits IPO Prospectus Following FDA Approval of Oral Medical Device PLENITY for Weight Management

VCBeat (WeChat Official Account: vcbeat) learned from foreign media that on April 14, U.S. local time, Gelesis, a biotechnology company headquartered in Boston, Massachusetts, announced that its prescription drug PLENITY (Gelesis100) had received FDA approval. Individuals with obesity can take this medication alongside dietary control and exercise to achieve weight management.

It is reported that the BMI (Body Mass Index) is 25 kg/m²²and above is defined as overweight, with a BMI of 30 kg/m²²and above is generally defined as obesity. Gelesis stated that when BMI is at 25 kg/m²up to 40 kg/m²within this range, adults require assisted weight management.

Obesity is a disease that increases patients’ risk of developing more than thirty other conditions, such as diabetes and non-alcoholic fatty liver disease (NAFLD). Surveys indicate that 70–80% of individuals with obesity have NAFLD, and 85% of patients with type 2 diabetes are overweight or obese.

To date, approximately 1.9 billion people worldwide are overweight, including 600 million who are obese. In the United States alone, two-thirds of the population is overweight or obese. While half of Americans express a strong desire to lose weight, most weight-loss attempts end in failure. Moreover, currently only a small proportion of obese patients pursue weight loss through prescription medications or surgery.

Schematic Diagram of PLENITY (Image sourced from the internet)

PLENITY is an oral, non-stimulant prescription medication that serves as a non-systemic aid for weight management. The drug consists of modified cellulose and citric acid as its basic structural units, forming a three-dimensional matrix. This matrix rapidly absorbs water in the stomach and mixes uniformly with ingested food, thereby generating thousands of small, individual gel particles. These gel particles possess the elasticity or firmness of food but have no caloric value; they occupy space within the gastric and small intestinal contents, inducing a sense of satiety. Once the gel particles enter the large intestine, they are partially degraded by enzymes, lose their three-dimensional structure, and consequently forfeit most of their water-absorbing capacity. The water released during degradation is reabsorbed by the large intestine, while the remaining cellulose material is excreted in the feces.

Notably, although PLENITY is administered orally, it has been classified as a medical device due to its unique mechanism of mechanical action.

To date, PLENITY has undergone pivotal studies, including multicenter, double-blind, placebo-controlled trials, evaluating weight changes in 436 overweight or obese adults after six months of treatment. Among patients taking PLENITY, 94% achieved more than 5% weight loss, with 26% classified as “super responders,” experiencing an average weight reduction of 14% (approximately 30 pounds). Notably, the most common adverse events associated with PLENITY were gastrointestinal disorders, such as abdominal distension, abdominal pain, diarrhea, constipation, and flatulence, followed by infections and musculoskeletal and connective tissue disorders.

Gelesis launched a targeted U.S. rollout of PLENITY in the second half of 2019, with PLENITY expected to be widely available by prescription across the United States in 2020.

Gelesis is a clinical-stage biotechnology company founded in 2006. The company has developed a novel hydrogel platform technology for the treatment of overweight, obesity, and chronic diseases associated with the gastrointestinal (GI) tract. Gelesis aims to potentially alter the course of chronic diseases by mechanically influencing the GI tract. Currently, the company’s product, Gelesis100, has received FDA approval as an aid in weight management. Gelesis is planning to develop its second candidate, Gelesis200, an optimized hydrogel designed for weight loss.

(Editor: Wang Chan)