Gelesis' PLENITY gains FDA clearance as an aid in weight loss for adults

Gelesis announced that the FDA has cleared PLENITY, also known as Gelesis100, the company's oral non-systemic, superabsorbent hydrogel, as an aid in weight management in adults with a body mass index (BMI) of 25 to 40. Gelesis said it plans to initiate a targeted US launch of PLENITY in the second half of 2019 and expects the product to be broadly available by prescription next year.

CEO Yishai Zohar remarked that the clearance will 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." He added that "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."

According to Gelesis, PLENITY is the only prescription weight management product to be cleared for use by overweight adults with a BMI as low as 25, with or without comorbidities such as hypertension, type 2 diabetes or dyslipidaemia. The company added that "there is no restriction on how long PLENITY can be used to assist in weight management."

PLENITY, which is administered in the form of capsules taken with water before lunch and dinner, is made by cross-linking modified cellulose and citric acid to create a three-dimensional matrix. "The capsules release thousands of non-aggregating particles that rapidly absorb water in the stomach, creating small individual gel pieces with the elasticity of plant-based foods without caloric value," the company explained, adding that 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."

Data from the pivotal GLOW study were published in the journal Obesity and presented at the Obesity Society annual meeting last November. The six-month trial enrolled 436 adults with a BMI of 27 to 40, and compared a 2.25-g dose of PLENITY, administered twice daily, to placebo, with all participants following a low-calorie diet and daily physical activity. The study met one of its two co-primary endpoints, with 59 percent of adults administered the product achieving clinically meaningful weight loss of 5 percent or more. However, the GLOW trial failed to hit the other co-primary goal of 3-percent mean difference from placebo.

Results from the study also demonstrated that 26 percent of adults on PLENITY achieved at least 10-percent weight loss, with the company noting that "these super-responders achieved an average of about 14-percent weight loss, or approximately 30 pounds." Further, the device showed no increased safety risk and no serious adverse events, as well as a lower dropout rate versus placebo.

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