GI Modulating Tunable Hydrogel

(Gelesis100, Gelesis200, GS300, GS400)

GI System

TRIAL PHASE
MECHANISMINDICATION(S)PRODUCT NAMEPreclinicalPhase 1Phase 2Phase 3
GI Modulating Hydrogel
Obesity, Diabetes, NAFLD, IBD
Gelesis
(Gelesis100, Gelesis200, GS300, GS400)

GI System

GI Modulating Hydrogel
INDICATION(S):Obesity, Diabetes, NAFLD, IBD
NAME:Gelesis (Gelesis100, Gelesis200, GS300, GS400)
STAGE:Phase 3
GI modulating tunable hydrogel

Gelesis100 is first of a new class of mechanotherapeutics to broadly treat obesity and related comorbidities. Based on a novel and tunable orally-administered hydrogel platform, Gelesis100 is designed to act locally and mechanically in the GI to induce satiety, weight loss and improve GI health. In Q3 2017, our affiliate Gelesis announced positive topline results from the pivotal weight loss study evaluating Gelesis100. Regulatory filings are anticipated with the U.S. Food and Drug Administration in the first half of 2018.

Gelesis recently initiated a proof-of-concept study for our second candidate, Gelesis200, which is optimized for weight loss and glycemic control in patients with type 2 diabetes and prediabetes. Gelesis is advancing a broad pipeline of additional product candidates to treat NASH/NAFLD, IBD, and acute and chronic intestinal injury. 


  • Patient Need & Market Potential
    • In the US, more than two thirds of adults are overweight or have obesity. Globally there are more than 1.9 billion adults 18 years of age or older who are overweight or had obesity 
    • Obesity-related conditions include heart disease, stroke, type 2 diabetes and certain types of cancer, some of the leading causes of preventable death. 
    • Approved oral therapies for weight loss have side-effects that limit their overall utility and limited efficacy
  • Our Approach to Solving the Problem
    • Given the challenges associated with pharmacological treatments for obesity, Gelesis decided to explore solutions that had a non-systemic mechanism of action (mechanical) with a strong safety and efficacy profile. In particular, Gelesis focused on a product profile with a natural cycling effect similar to ingested food that would be non-invasive and require no procedure for introduction or removal 
    • Gelesis' product candidates work in the GI tract and pass through the body without being absorbed. They are made from two naturally-derived food ingredients (citric acid and modified cellulose) that form a three-dimensional matrix and occupy volume in the stomach and small intestine to induce weight loss and reduce insulin resistance
  • Intellectual Property
    • The Gelesis platform has broad worldwide coverage including over 129 issued patents and patent applications in eight families of patent filings
    • The filings cover pharmaceutical composition of matter, methods of use and methods of production for its product candidates. In addition, the team also has significant know-how, trade secrets and continuing technological innovation to develop and maintain its proprietary position
  • Team

    The Gelesis team has extensive expertise in obesity research and materials science to develop and commercialize its product candidates 

    • Key advisors include:

      Dr. Caroline Apovian, one of the world’s premier weight-loss experts and New York Times bestselling author, Director of the Nutrition and Weight Management Center, Boston Medical Center;

      Dr. Louis J. Aronne, a leading authority on obesity and its treatment, Professor of Metabolic Research at Weill-Cornell Medical College;

      Dr. Lee M. Kaplan, the Director of the Obesity, Metabolism & Nutrition Institute, founding director of the Weight Center at the Massachusetts General Hospital;

      Dr. Arne Astrup, global leader in obesity and research, Director of Department of Nutrition, Exercise and Sports for Faculty of Science at University of Copenhagen;

      Dr. Ken Fujioka, an internal medicine practitioner whose clinical expertise centers around weight management, nutrition and metabolic disorders;

      Dr. Allan Geliebter, Senior Attending Psychologist and member of the New York Obesity Nutrition Research Center at St Luke’s-Roosevelt Hospital;

      Dr. James Hill, Professor of Medicine & Pediatrics at the University of Colorado, Past President of The Obesity Society (TOS); Angelo Tremblay, professor in the Department of Kinesiology at Laval University;  

      Dr. John LaMattina, former President of Pfizer Global Research and Development and Senior Vice President of Pfizer, Inc. and current Independent Non-Executive Director at PureTech Health;

      Mr. Elon Boms, Founder & Chairman at Launch Capital; and

      Dr. Raju Kucherlapati, founder and formerly a Board Member of Abgenix (Acquired by Amgen), and Milennium Pharmaceuticals (acquired by Takeda), and Independent Non-Executive Director at PureTech Health.

    Gelesis was developed and is led by Mr. Yishai Zohar, Dr. Eyal Ron, Dr. David Pass, Dr. Hassan Heshmati, and Dr. Alessandro Sannino

  • Milestones Achieved
    • Gelesis achieved significant weight loss with an excellent safety profile in its pivotal Gelesis Loss of Weight (GLOW) clinical trial with Gelesis100. The study achieved and exceeded one of two co-primary endpoints, with 59% of adults in the Gelesis100 treatment arm achieving 5% or more weight loss. Additionally, almost twice as many adults on Gelesis100 lost 10% or more of their body weight compared to the placebo group (p=0.027).
    • Having completed a first-in-man study demonstrating positive efficacy and safety results, Gelesis has initiated a six-month efficacy proof-of-concept study (LIGHT-UP) with Gelesis200 in people with prediabetes or untreated diabetes, with results expected in 2018.
    • The Italian Ministry of Economic Development awarded €2.9 million to our research and development subsidiary in Italy for the advancement of our novel hydrogel platform for the treatment of type 2 diabetes.
  • Collaborations
    • Further investigation of our tunable hydrogel mechanism has led to an international collaboration with leading obesity and nutrition experts – and subsequent publication in the American Journal of Clinical Nutrition – building on a novel and proprietary biomarker approach for people with prediabetes (See publications) and a paper in the International Journal of Obesity showing that Pre-treatment microbial ratio determines body fat loss success during a 6-month randomized controlled diet intervention
  • Expected Milestones and Timing
    • Regulatory filings anticipated with the U.S. Food and Drug Administration in the first half of 2018
    • Results are anticipated from the Gelesis200 LIGHT-UP study for weight loss and glycemic control in people with prediabetes or type 2 diabetes in 2018
    • Additional human pilot studies in NASH/NAFLD are planned

     

Gelesis consists of a novel tunable hydrogel platform that can be optimized based on volumetric, viscosity and elasticity features to have effects in different parts of the gastrointestinal system.

These properties are being explored in additional GI-related therapeutic areas, as we have observed a positive impact on gut health related indications with our proprietary hydrogel system.


Innovative Approach


3 Month, Randomized Placebo Controlled POC Study