Gelesis, a biotechnology company developing a novel hydrogel platform technology to treat obesity and other chronic diseases related to the gastrointestinal (GI) tract, has received approval to market Plenity, a novel weight loss treatment, in Europe. Gelesis received a Conformité Européenne (CE) mark for Plenity as a class III medical device indicated for weight loss in overweight and obese adults with a BMI25-40, when used in conjunction with diet and exercise.
“Seventy percent of the western world is affected by overweight or obesity and there are few non-invasive, non-systemic solutions without major risks,” said Professor John Wilding, a clinical researcher Obesity, Diabetes and Endocrinology at the University of Liverpool and the incoming president of the World Obesity Federation. “Through my participation in the clinical trial, I saw first-hand the impact Plenity can have. The CE mark will further broaden access to a weight loss option that can impact tens of millions of patients globally.”
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 BMI25–40, 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 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 eliminated through the body’s natural digestive processes. Plenity is considered a medical device because it achieves its primary intended purpose through mechanical modes of action consistent with mechanobiology constructs.
The CE mark indicates that Plenity has been assessed to meet health and safety standards for products sold within the European Economic Area (EEA), as required by the European Medical Device Directives. Gelesis will now be able to market Plenity throughout the EEA and in other countries that recognize the CE mark.
“Obesity is a global public health crisis, and too many individuals have struggled to lose weight on their own, without an effective therapeutic intervention to help them. We believe Plenity is a highly differentiated option for this serious public health issue,” said Yishai Zohar, founder and chief executive officer of Gelesis. “Receiving the CE mark is an important milestone for the Gelesis team and for our hydrogel technology platform.”
Gelesis plans to bring Plenity to the US first, where it is now available by prescription to a limited extent while the company ramps up its commercial operations and inventory for a broad launch in 2021.