New Plenity™ Pivotal Safety and Efficacy Data to be Presented at ObesityWeek 2019

BOSTON--()--Gelesis, a biotechnology company developing a novel hydrogel platform technology to treat obesity and other chronic diseases related to the gastrointestinal (GI) tract, today announced that the Company will deliver two oral presentations and one poster at ObesityWeek 2019, the annual combined congress of the American Society for Metabolic and Bariatric Surgery and The Obesity Society in Las Vegas, Nevada, from November 3-7, 2019. The presentations will detail data regarding the safety and efficacy of Plenity™ (Gelesis100), including a new subgroup analysis of patients achieving a Body Mass Index (BMI) of at least 27 kg/m2 in the company’s pivotal Gelesis Loss of Weight (GLOW) clinical trial. Plenity is an oral, non-systemic therapeutic cleared by the FDA as an aid for weight management in adults with a Body Mass Index (BMI) of 25–40 kg/m2, when used in conjunction with diet and exercise.

“More than half of the approximately 150 million adults in the U.S. with a BMI ranging from 25 kg/m2 to 40 kg/m2 are classified as overweight (BMI 25-30 kg/m2). Until now, many of them have not had access to prescription treatment options,” commented Harry L. Leider, MD, MBA, FACPE, Chief Medical Officer of Gelesis. “As the only prescription weight management product cleared for use by overweight adults with a BMI as low as 25 kg/m2, we are eager to share new pivotal data which underscores the safety and efficacy of Plenity in patients in the overweight range as well as the broader range of obesity – up to a BMI of 35 kg/m2. This new data highlights the unique opportunity Plenity creates to treat adults struggling to achieve a healthy weight earlier than previously possible with other prescription therapeutics.”

Details of the presentations are as follows:

Tuesday, November 5, 2019: 1:00 pm PT-3:00 pm PT, Drugs and Devices - New Interventions, and New Perspectives on Trusted Standbys

  • Safety of Gelesis100 in Subjects Who Reached a Body Mass Index Below 27 kg/m2 in the GLOW Study; Louis J. Aronne, MD, FACP, Sanford I. Weill Professor of Metabolic Research, Weill-Cornell Medical College
  • Safety of Gelesis100 in Overweight or Obesity: Comprehensive Analysis of the GLOW Study; Ken Fujioka, MD, Director of the Nutrition and Metabolic Research Center and the Center for Weight Management, Scripps Clinic

Thursday, November 7, 2019: 12:00 pm ET-1:30 pm PT, poster presentation

  • Assessment of Early Intervention with Gelesis100 in Overweight and Mild Obesity in the GLOW Study; Frank L. Greenway, MD, Medical Director and Professor at the Pennington Biomedical Research Center, Louisiana State University System (T-P-3542)

About Plenity™ (Gelesis100)
Plenity is an oral, non-systemic, superabsorbent hydrogel which has received FDA clearance as an aid in weight management in adults with overweight and obesity 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 oxide.
  • Plenity may alter the absorption of medications. Read Sections 6 and 8.3 of the Instructions for Use carefully.
  • 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 from the placebo group.

Rx Only. For the safe and proper use of Plenity, refer to the 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. Gelesis anticipates Plenity will be broadly available by prescription in the U.S. in late 2020. 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).

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), a biopharmaceutical company focused on the Brain-Immune-Gut (BIG) axis. For more information, visit gelesis.com or connect with us on Twitter @GelesisInc.

Contacts

Allison Mead Talbot
+1 617 651 3156
amt@puretechhealth.com

Release Summary

New Plenity Pivotal Safety and Efficacy Data to be Presented at ObesityWeek 2019

Contacts

Allison Mead Talbot
+1 617 651 3156
amt@puretechhealth.com