Product Candidate**
PureTech Ownership
Initial Indications
Preclinical
Phase 1
Phase 2
Phase 3
PLENITY
22.0% (Gelesis)
Weight Management
FDA Cleared

Initial Indication(s):

Overweight and obesity

Patient Population:

~150M US

Collaborators:

UdelSalento

Key Differenciation:

Gelesis is developing oral therapeutics based on a novel, superabsorbent hydrogel technology platform to treat obesity and other 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 chronic diseases. Gelesis received clearance from the FDA for its first product, PLENITY (Gelesis100), and has additional programs in development for indications including NASH/NAFLD and CIC.

GS500*
22.0% (Gelesis)
CIC

Initial Indication(s):

CIC

Patient Population:

~35M

Collaborators:

UdelSalento

Key Differenciation:

Gelesis is developing oral therapeutics based on a novel, superabsorbent hydrogel technology platform to treat obesity and other 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 chronic diseases. Gelesis received clearance from the FDA for its first product, PLENITY (Gelesis100), and has additional programs in development for indications including NASH/NAFLD and CIC.

Gelesis200*
22.0% (Gelesis)
Weight Management in T2D/Prediabetes

Initial Indication(s):

Weight management in T2D/prediabetes

Patient Population:

~114M

Collaborators:

UdelSalento

Key Differenciation:

Gelesis is developing oral therapeutics based on a novel, superabsorbent hydrogel technology platform to treat obesity and other 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 chronic diseases. Gelesis received clearance from the FDA for its first product, PLENITY (Gelesis100), and has additional programs in development for indications including NASH/NAFLD and CIC.

GS300*
22.0% (Gelesis)
NASH/NAFLD

Initial Indication(s):

NASH/NAFLD

Patient Population:

80 – 100M

Collaborators:

UdelSalento

Key Differenciation:

Gelesis is developing oral therapeutics based on a novel, superabsorbent hydrogel technology platform to treat obesity and other 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 chronic diseases. Gelesis received clearance from the FDA for its first product, PLENITY (Gelesis100), and has additional programs in development for indications including NASH/NAFLD and CIC.

GS400*
22.0% (Gelesis)
IBD

Initial Indication(s):

IBD

Patient Population:

~3M

Collaborators:

UdelSalento

Key Differenciation:

Gelesis is developing oral therapeutics based on a novel, superabsorbent hydrogel technology platform to treat obesity and other 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 chronic diseases. Gelesis received clearance from the FDA for its first product, PLENITY (Gelesis100), and has additional programs in development for indications including NASH/NAFLD and CIC.



PLENITY
Weight Management
22.0% (Gelesis)
Phase 3
FDA Cleared

Initial Indication(s):

Overweight and obesity

Patient Population:

~150M US

Collaborators:

UdelSalento

Key Differenciation:

Gelesis is developing oral therapeutics based on a novel, superabsorbent hydrogel technology platform to treat obesity and other 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 chronic diseases. Gelesis received clearance from the FDA for its first product, PLENITY (Gelesis100), and has additional programs in development for indications including NASH/NAFLD and CIC.

GS500*
CIC
22.0% (Gelesis)
Phase 2

Initial Indication(s):

CIC

Patient Population:

~35M

Collaborators:

UdelSalento

Key Differenciation:

Gelesis is developing oral therapeutics based on a novel, superabsorbent hydrogel technology platform to treat obesity and other 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 chronic diseases. Gelesis received clearance from the FDA for its first product, PLENITY (Gelesis100), and has additional programs in development for indications including NASH/NAFLD and CIC.

Gelesis200*
Weight Management in T2D/Prediabetes
22.0% (Gelesis)
Phase 2

Initial Indication(s):

Weight management in T2D/prediabetes

Patient Population:

~114M

Collaborators:

UdelSalento

Key Differenciation:

Gelesis is developing oral therapeutics based on a novel, superabsorbent hydrogel technology platform to treat obesity and other 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 chronic diseases. Gelesis received clearance from the FDA for its first product, PLENITY (Gelesis100), and has additional programs in development for indications including NASH/NAFLD and CIC.

GS300*
NASH/NAFLD
22.0% (Gelesis)
Preclinical

Initial Indication(s):

NASH/NAFLD

Patient Population:

80 – 100M

Collaborators:

UdelSalento

Key Differenciation:

Gelesis is developing oral therapeutics based on a novel, superabsorbent hydrogel technology platform to treat obesity and other 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 chronic diseases. Gelesis received clearance from the FDA for its first product, PLENITY (Gelesis100), and has additional programs in development for indications including NASH/NAFLD and CIC.

GS400*
IBD
22.0% (Gelesis)
Preclinical

Initial Indication(s):

IBD

Patient Population:

~3M

Collaborators:

UdelSalento

Key Differenciation:

Gelesis is developing oral therapeutics based on a novel, superabsorbent hydrogel technology platform to treat obesity and other 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 chronic diseases. Gelesis received clearance from the FDA for its first product, PLENITY (Gelesis100), and has additional programs in development for indications including NASH/NAFLD and CIC.

Targeting the GI system locally to treat the genesis of chronic disease

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. The Gelesis portfolio includes a product for weight management in overweight and obese patients and a pipeline with potential therapies for Non-alcoholic Fatty Liver Disease (NAFLD)/Non-alcoholic Steatohepatitis (NASH), weight management in T2D/prediabetes, Chronic Constipation (CIC) and inflammatory bowel disease (IBD).

Gelesis' first FDA-cleared product, PLENITYTM

In April 2019, Gelesis received clearance from the United States Food and Drug Administration (FDA) for its first product, Plenity (Gelesis100), 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.

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.

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


Plenity Gelesis received FDA clearance for PlenityTM as an aid for weight management in adults with a BMI of 25-40 kg/m2 when used in conjunction with diet and exercise


Plenity go-to-market approach


Press Releases


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 PlenityTM 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, 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