GI Modulating Tunable Hydrogel

(Gelesis100, Gelesis200)

GI System

GI Modulating Tunable Hydrogel
Obesity, Diabetes, Intestinal Injury, NAFLD, IBD
(Gelesis100, Gelesis200, GS300, GS400)

GI System

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

Gelesis100 is the first of a new class of mechanotherapeutics. This product is based on a novel and tunable orally administered hydrogel platform designed to safely treat obesity and related comorbidities by acting locally in the GI to induce satiety, weight loss and improve GI health. We expect a pivotal study to read-out in 2017, with potential FDA approval in late 2018.

Our second product candidate Gelesis200, created from the same proprietary technology program as Gelesis100, is a product optimized to induce weight loss and improve glycemic control in patients with type 2 diabetes. Gelesis200’s six-month efficacy proof-of-concept study is expected to read out in mid-2018. Additional product candidates based on this platform are being explored in NASH/NAFLD and intestinal mucositis.

  • 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, we decided to explore solutions that had a non-systemic mechanism of action (mechanical) with a strong safety and efficacy profile. In particular, we 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 
    • Our 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 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.

    • The program was developed and is led by Mr. Yishai Zohar, Dr. Eyal Ron, Dr. David Pass, Dr. Hassan Heshmati, and Dr. Alessandro Sannino
  • Milestones Achieved
    • In July 2017, we reported that the last patient completed treatment in the pivotal GLOW (Gelesis Loss Of Weight) Study. The GLOW study was designed to assess the long-term efficacy and safety of lead product candidate Gelesis100 over a six-month period across a broad patient population. The results of the study are expected in Q3 2017
    • The first European patient was enrolled in the ongoing LIGHT-UP study with second product candidate, Gelesis200, for weight loss and glycemic control. The study will enroll individuals who are overweight or have obesity and also have prediabetes or metformin-treated type 2 diabetes at more than 30 sites across the United States, Canada, and Europe
    • 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.
    • In a completed 128-patient, 3-month human proof-of-concept clinical trial, Gelesis100 demonstrated in the 2.25g-dose arm: 

    - Statistically significant weight loss versus placebo, with even more dramatic weight loss in the prediabetic subpopulation 

    - At least 10% mean weight loss in 26% of patients; at least 5% mean weight loss in 43% of patients 

    - A majority of prediabetic patients returned to normal fasting blood glucose status 

    - Excellent safety profile 

    • In 2016, the team presented new data for Gelesis200 at ObesityWeek, the annual combined congress of the American Society for Metabolic and Bariatric Surgery and The Obesity Society. Data from this first-in-human study demonstrated that administration 10 minutes prior to a meal increased fullness throughout the entire day (P = 0.012).
    • Blinded controlled pilot studies have shown statistically significant increased satiety and reduced hunger for both Gelesis100 and Gelesis200 
  • 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
    • The results from the Gelesis100 GLOW pivotal weight-loss study, a potentially registration-enabling trial are anticipated in Q3 2017, with subsequent PMA and CE mark filings with the FDA and EU, respectively, if the results are positive
    • The results from the Gelesis200’s six-month efficacy proof of concept study is expected to read out in mid-2018
    • Additional human pilot studies in Intestinal Mucositis and NASH/NAFLD are planned

This program 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