Puretech Ownership
Product Candidate
Initial Indication(s)
Stage of Development
21.0% Equity plus Royalties
Plenity®3,4

Weight management

FDA Cleared,
European CE Mark Granted
GS1004,5

Adolescent weight management

Seeking FDA input for expanding Plenity label to treat adolescents6
GS2004,5

Weight management in type 2 diabetes (T2D)/prediabetes

Phase 2
GS3004,5

Non-alcoholic steatohepatitis/Non-alcoholic fatty liver disease

Phase 2 Ready6
GS5004,5

Functional constipation

Phase 3 Ready6

4. These product candidates are regulated as devices and their development has been approximately equated to phases of clinical development.

5. Products are investigational and have not been cleared by the FDA for use in the United States.

6. Contingent on FDA review of the research plan.

Plenity®, FDA-cleared and approved to market in Europe 

Gelesis is developing oral therapeutics based on a novel, superabsorbent hydrogel technology platform to treat excess weight and other chronic diseases related to the gastrointestinal (GI) pathway. Gelesis’ proprietary approach is designed to act mechanically in the GI pathway to potentially alter the course of chronic diseases. 

Gelesis is progressing a global commercialization strategy for its first product, Plenity, to broaden global access to a weight loss option. Gelesis plans to bring Plenity to the U.S. first, where it has been available to a limited extent since the second half of 2019 through an early experience program and since 2020 via a limited launch, while the company ramps up its commercial operations and inventory for a full launch in 2021.

  • In April 2019, Gelesis received clearance from the United States Food and Drug Administration (FDA) for its first product, Plenity (Gelesis100), 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. 
  • In June 2020, 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, or BMI, of 25-40 kg/m2 when used in conjunction with diet and exercise, which allows Gelesis to market Plenity throughout the European Economic Area and in other countries that recognize the CE Mark.
  • Gelesis has a partnership with Ro, a leading U.S. telehealth provider, to support the U.S. commercialization of Plenity. Through the Gelesis-Ro partnership, Plenity will be the first FDA-cleared weight management aid and first primary care product to launch with both traditional healthcare provider and telehealth services, making Plenity available to patients nationwide. 
  • Gelesis has a partnership with China Medical System Holdings Ltd. for the commercialization of Plenity in China.

For more information, visit www.myplenity.com.

GLOW Clinical Study Details

The Gelesis Loss of Weight (GLOW) study was a multicenter, double-blind, placebo-controlled pivotal study designed to assess change in body weight in 436 adults with overweight or obesity (BMI ≥ 27 and ≥ 40 kg/m2) after six months of treatment. The study had two predefined co-primary endpoints: at least 35 percent of patients taking Plenity achieving more than five percent weight loss (categorical endpoint) and placebo-adjusted weight loss with a super-superiority margin of three percent. In addition, a prespecified analysis of simple superiority was also performed. The study met and exceeded the predefined categorical endpoint, with 59 percent of adults in the treatment group achieving weight loss of five percent or greater and losing on average 10 percent of their weight (22 pounds) and 3.5 inches from their waists within six months. The study did not meet the three percent super-superiority endpoint but demonstrated superiority of the Plenity treatment over the placebo group (–6.4 percent vs. –4.4 percent, P=0.0007). Plenity-treated individuals had twice the odds of achieving at least five percent weight loss as compared to placebo (adjusted odds ratio: 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 dioxide.
  • 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.
  • The overall incidence of adverse events (AEs) in the Plenity group was no different than the placebo group.
  • The most common side effects were diarrhea, distended abdomen, infrequent bowel movements, and flatulence.

For the safe and proper use of Plenity, refer to U.S. Instructions for Use or the EU Instructions for Use.

Clinical results from GLOW

A six-month pivotal study

In an additional analysis

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. *Prespecified ITT-Observed result.


Press Releases


PureTech Founded Entity Gelesis Presents Plenity® Efficacy and Safety Data at the European and International Congress on Obesity 2020

September 4, 2020


PureTech Founded Entity Gelesis Announces Partnership for Commercial Launch of Plenity® in China

June 18, 2020


PureTech Founded Entity Gelesis Receives Approval to Market PLENITY™ in Europe as a Weight Loss Treatment 

June 2, 2020


PureTech Affiliate Gelesis Named One of the World’s Most Innovative Companies for 2020 by Fast Company

March 11, 2020


PureTech Health Affiliate Gelesis Announces Partnership with Ro to Support US Commercialisation of Plenity™

December 17, 2019


PureTech Health Affiliate Gelesis Secures Over $84 Million in New Capital to Support US Commercialisation of PLENITY™

December 9, 2019

 

PureTech Affiliate Gelesis Presents Additional Data Highlighting Therapeutic Benefits of Plenity at ObesityWeek 2019

November 5, 2019


PureTech Health Affiliate Gelesis Announces Promising Pilot Clinical Data From Prototype of GS500 In Development for Chronic Idiopathic Constipation

May 20, 2019


PureTech Health Affiliate Gelesis Announces $10.6 (€9.4) Million Grant to Support Commercial Manufacturing of PLENITY™

April 25, 2019

 

PureTech Health Affiliate Gelesis Announces Successful FDA Milestone for First Product, PLENITY

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