GELESIS
(PLENITYTM, Gelesis200, GS300, GS400, GS500)
Initial Indication(s):
Patient Population:
Collaborators:
Key Differentiation:
Only prescription weight management product to be cleared for use by overweight adults with a BMI as low was 25 kg/m2, with and without comorbidities such as hypertension, type 2 diabetes, or dyslipidemia
Initial Indication(s):
Patient Population:
Collaborators:
Key Differentiation:
Designed an approach for weight loss with an oral, non-invasive, non-systemic mechanism of action
Initial Indication(s):
Patient Population:
Collaborators:
Key Differentiation:
Designed an approach for weight loss with an oral, non-invasive, non-systemic mechanism of action
Initial Indication(s):
Patient Population:
Collaborators:
Key Differentiation:
Designed an approach for weight loss with an oral, non-invasive, non-systemic mechanism of action
Initial Indication(s):
Patient Population:
Collaborators:
Key Differentiation:
Designed an approach for weight loss with an oral, non-invasive, non-systemic mechanism of action
Initial Indication(s):
Patient Population:
Collaborators:
Key Differentiation:
Only prescription weight management product to be cleared for use by overweight adults with a BMI as low was 25 kg/m2, with and without comorbidities such as hypertension, type 2 diabetes, or dyslipidemia
Initial Indication(s):
Patient Population:
Collaborators:
Key Differentiation:
Designed an approach for weight loss with an oral, non-invasive, non-systemic mechanism of action
Initial Indication(s):
Patient Population:
Collaborators:
Key Differentiation:
Designed an approach for weight loss with an oral, non-invasive, non-systemic mechanism of action
Initial Indication(s):
Patient Population:
Collaborators:
Key Differentiation:
Designed an approach for weight loss with an oral, non-invasive, non-systemic mechanism of action
Initial Indication(s):
Patient Population:
Collaborators:
Key Differentiation:
Designed an approach for weight loss with an oral, non-invasive, non-systemic mechanism of action
Targeting the Gastrointestinal (GI) Tract to Treat the Genesis of GI-Related Chronic Diseases
Our affiliate Gelesis is a biotechnology company developing first-in-class oral therapeutics based on a novel, superabsorbent hydrogel technology platform to treat obesity and other chronic diseases related to the GI pathway. The Gelesis portfolio includes a product for obesity and overweight and a pipeline with potential therapies for Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH), Type 2 diabetes and Chronic Constipation (CIC).
Gelesis' first FDA-cleared product, PLENITYTM
In April 2019, Gelesis received FDA clearance for PLENITYTM (Gelesis100) as an aid for weight management in conjunction with diet and exercise. PLENITY is indicated to aid in weight management in adults who are overweight or obese and have a body mass index (BMI) of 25 to 40 kg/m² when combined with diet and exercise. In clinical trials, side effects with PLENITY were similar to placebo (sugar pill). The most common side effects were fullness, bloating, flatulence, and/or abdominal pain.
For more information, visit www.myplenity.com.
GLOW Clinical Study Details
The Gelesis Loss of Weight (GLOW) study was a 24-week, multicenter, randomized, double-blind, placebo-controlled pivotal trial assessing the safety and efficacy of PLENITY. PLENITY was administered to 436 overweight and obese adults, with or without type 2 diabetes. Adults were randomized to 2.25 g of PLENITY or placebo and were prescribed reduced caloric intake and exercise. The two co-primary endpoints calculated from baseline to month 6 were: 1) ≥35% of individuals taking PLENITY achieving ≥5% weight loss (categorical endpoint), and 2) a placebo-adjusted weight loss assessed in two ways: superiority margin of 3% and simple superiority over placebo. The study met and exceeded the categorical endpoint (59% achieved ≥5% weight loss). It did not achieve super-superiority; however it did achieve superiority over placebo (-6.4% vs -4.4%, P=0.0007). Individuals taking PLENITY had twice the odds of achieving ≥5% weight loss vs placebo (adjusted odds ratio [OR] was 2.0 [P=0.0008]).
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 TRAEs with 38% of adults in the PLENITY group and 28% of adults in the placebo group experiencing a GI-related TRAE.
- The overall incidence of AEs in the PLENITY group was no different than the placebo group.
Rx Only. For the safe and proper use of PLENITY, refer to the Instructions for Use.
References: 1. Plenity™ [instructions for use]. Boston, MA: Gelesis, Inc.; 2019. 2. Greenway FL, Aronne, LJ, Raben A, et al. A randomized, double-blind, placebo-controlled study of Gelesis100: A novel nonsystemic oral hydrogel for weight loss. Obesity. 2019;27(2):205-216.
We also recently initiated a proof-of-concept study for our second product candidate, Gelesis200, which is optimized for weight loss and glycemic control in patients with type 2 diabetes or prediabetes. We are advancing a broad pipeline of programs using our novel and tuneable orally-administered hydrogel platform for the treatment of additional obesity-related co-morbidities, including liver diseases such as non-alcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD), along with GI disorders such as inflammatory bowel disease (IBD) and intestinal mucositis.
KEY FEATURES
Press Releases
PureTech Health Affiliate Gelesis Announces Successful FDA Milestone for First Product, PLENITYTM
April 14, 2019
PureTech’s Affiliate Gelesis Presents Data at ENDO Demonstrating Lead Product Candidate’s Positive Effect on Patients With Prediabetes, Untreated Diabetes, and Elevated Insulin Resistance
March 25, 2019
PureTech Health Affiliate Gelesis Presents Preclinical Data Showing Pipeline Candidate Restores Gut Barrier Function
March 25, 2019
PureTech's Affiliate Gelesis Announces Three Presentations at Endocrine Society Annual Meeting
March 21, 2019
Pivotal Weight Loss Data for Gelesis100 Published in Obesity, Including Predictors of Response
November 13, 2018
PureTech's Gelesis to Present Expanded Pivotal Data for Lead Product Candidate at ObesityWeek 2018
November 5, 2018
A Randomized, Double-Blind, Placebo-Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss
November 2018
Pretreatment fasting plasma glucose and insulin modify dietary weight loss success: results from 3 randomized clinical trials
July 2017
Pretreatment Fasting Glucose Predicts Weight Loss on High Fiber, Low Glycemic Load Diet presented at American Diabetes Association
June 2017
Satiety, Weight Loss, and Glycemic Control-Enhancing properties of Gelesis200 presented at European Congress on Obesity
May 2017
Effects of Gelesis200 on fullness and satiety presented at TOS Obesity Week.
November 2016