New edible hydrogel capsule approved by FDA for obesity treatment

Weighing Scale

The edible hydrogel capsule, called Plenity has received De Novo clearance from FDA for treatment of obesity

Plenity is an oral, superabsorbent hydrogel capsule 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.

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 is made by cross-linking 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 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 feces.

The hydrogel capsule is taken with water before lunch and dinner. The product is considered a medical device because it achieves its purpose through mechanical mode of action.

Data from the Plenity pivotal study, Gelesis Loss Of Weight (GLOW), were published recently in the scientific journal Obesity that showed effectiveness, meeting its primary endpoint with 59% of patients who received the treatment losing at least 5% of their weight, compared to 42% in the placebo group. The treatment also had a favorable safety and tolerability profile.

The most compelling aspects of this approach are its effectiveness, novel mechanism of action and impressive safety data

Side effects in patients treated with plenity were similar to those seen in the placebo group, with the most common being fullness, bloating, flatulence and abdominal pain. The most common treatment related adverse events were gastrointestinal disorders in 38% of patients who took the Plenity capsules, compared to 28% in those who received the placebo.

“The most compelling aspects of this approach are its effectiveness, novel mechanism of action and impressive safety data. This approach creates another arm in the treatment algorithm of  weight management and could be used by an overwhelming majority of people struggling with weight issues,” said Ken Fujioka, M.D., a weight loss expert, endocrinology researcher at Scripps Clinic and scientific advisor to Gelesis.

Plenity (Gelesis100) is manufactured by an US biotechnology company called Gelesis which was co-founded by biopharma company PureTech. The company plans to launch the weight loss aid in the second half of 2019.