CE Mark enables Gelesis to market Plenity™ throughout the European Economic Area
BOSTON–(BUSINESS WIRE)–Gelesis, a biotechnology company developing a novel hydrogel platform technology to treat obesity and other chronic diseases related to the gastrointestinal (GI) tract, announced today that it 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 Body Mass Index (BMI) of 25-40 kg/m2, 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,” says John Wilding, M.D., FRCP, 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 firsthand 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.”
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 U.S. 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.
About Plenity™
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 BMI of 25–40 kg/m2, 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. For more information, visit myplenity.com.
Important Safety Information
- PLENITY is contraindicated in patients who are pregnant or are allergic to cellulose, citric acid, sodium stearyl fumarate, gelatin or titanium dioxide.
- PLENITY may alter the absorption of medications.
- Avoid use in patients with the following conditions: esophageal anatomic anomalies, including webs, diverticuli, and rings; suspected strictures (such as patients with Crohn’s disease); or complications from prior gastrointestinal (GI) surgery that could affect GI transit and motility.
- Use with caution in patients with active GI conditions such as gastro-esophageal reflux disease (GERD), ulcers or heartburn.
- Overall, the most common treatment related adverse events (TRAEs) were GI-related with 38% of adults in the PLENITY group and 28% of adults in the placebo group.
- The overall incidence of adverse events (AEs) in the PLENITY group was no different than the placebo group.
For the safe and proper use of PLENITY, refer to the U.S. Instructions for Use or the EU Instructions for Use.
About Gelesis
Gelesis is developing a novel hydrogel platform technology to treat overweight and obesity and chronic diseases related to the GI pathway. Gelesis’ proprietary approach is designed to act mechanically in the GI pathway to potentially alter the course of certain chronic diseases. In April 2019, Gelesis received FDA clearance for its lead product candidate, Plenity™, as an aid for weight management in overweight and obese adults with a Body Mass Index (BMI) of 25-40 kg/m2, when used in conjunction with diet and exercise. Plenity is currently available in limited supply in the U.S. Additionally, Gelesis is developing its second investigational candidate, Gelesis200, a hydrogel optimized for weight loss and glycemic control in patients with type 2 diabetes and prediabetes. Novel hydrogel mechanotherapeutics based on the Gelesis platform technology are also being advanced in other GI inflammatory conditions, such as non-alcoholic steatohepatitis (NASH) and Chronic Idiopathic Constipation (CIC). Gelesis was named one of Fast Company’s Most Innovative Companies for 2020.
The Gelesis executive and advisory team includes some of the world’s leading experts in obesity, materials science, chronic disease research, and commercialization. Gelesis was co-founded by PureTech Health (LSE: PRTC). For more information, visit gelesis.com or connect with us on Twitter @GelesisInc.
Contacts
Katie Sullivan
+1 857 201 5309
ksullivan@gelesis.com