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
(21.0%*)

GI System

GI Modulating Hydrogel
INDICATION(S):Obesity, Diabetes, NAFLD, IBD
NAME:Gelesis (21.0%*)
STAGE:Phase 3
GI modulating tunable hydrogel

Our affiliate Gelesis is developing first-in-class mechanotherapeutics to treat chronic diseases related to the gastrointestinal (GI) pathway. Our proprietary approach leverages rheological properties to act mechanically in the GI pathway to potentially alter the course of chronic diseases safely and effectively. In September 2017, we announced positive results from a pivotal trial for weight loss evaluating our lead product candidate, Gelesis100. Based on these results, as well as existing data, we plan to submit Gelesis100 for regulatory approval in the U.S. and Europe in 2018.

 


  • Patient Need & Market Potential
    • In the U.S., 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 and invasive surgical treatments for obesity, we designed an approach with an oral, non-invasive, 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 natural food ingredients (citric acid and cellulose) that form a novel three-dimensional structure composition that is proprietary (patent protected) and occupies volume in the stomach and small intestine to induce weight loss and other benefits.
    • Because our technology acts mechanically and is not systemically absorbed, the product candidates are treated as devices for regulatory approval purposes.
  • Intellectual Property
    • Our platform has broad intellectual property coverage worldwide, including 176 patent applications and issued patents in 12 families of patent filings in the U.S. and numerous foreign jurisdictions, including EU, Canada, Japan, Russia, and South Korea.
    • The filings cover pharmaceutical composition of matter, methods of use, and methods of making polymer hydrogels for use in weight management and glycemic control, as well as predicting weight loss and treating obesity.
  • 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. David Pass, Dr. Hassan Heshmati, Dr. Elaine Chiquette, and Dr. Alessandro Sannino.

  • Milestones Achieved
    • We achieved significant weight loss with an excellent safety profile in its pivotal clinical trial with Gelesis100. The study achieved and exceeded one of two co-primary endpoints, with 59 percent of adults in the Gelesis100 treatment arm achieving 5 percent or more weight loss compared to placebo (59 percent vs. 42 percent, p=0.0008). Additionally, almost twice as many adults on Gelesis100 lost 10 percent or more of their body weight compared to the placebo group (26 percent vs. 16 percent, p=0.027). Gelesis100 showed no increased safety risk, no serious adverse events, and a lower dropout rate compared to placebo.
    • In 2016, we presented positive safety and satiety efficacy data from a first-in-human study of Gelesis200, showing that Gelesis200 was generally well-tolerated with no serious adverse events. Based on these positive results, we initiated a six-month efficacy proof-of-concept study in people with prediabetes or diabetes, with results expected within the next 12 months.
    • To date, we have completed seven clinical trials with more than 550 people treated with either Gelesis100 or Gelesis200, demonstrating no increased safety risks and no serious adverse events.
  • Collaborations
    • In March 2018, Gelesis completed a private fundraising round with gross proceeds of $30 million. The proceeds from the financing will be used to support commercial-stage manufacturing, product launch preparations, company operations, and the clinical advancement of our pipeline of additional product candidates for gastrointestinal disorders, including type 2 diabetes and NASH/NAFLD.
    • The Italian Ministry of Economic Development awarded €2.9 million to the Gelesis research and development subsidiary in Italy for the advancement of our novel hydrogel platform for the treatment of type 2 diabetes.
    • Further investigation of our hydrogel technology platform 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, 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.
    • In 2015, we raised over $50 million in equity financing, with more than $40 million of that coming from external investors.
  • Expected Milestones and Timing
    • Regulatory filings are anticipated in the U.S. and Europe in 2018 for Gelesis100.
    • Results are anticipated from the Gelesis200 LIGHT-UP study for weight loss and glycemic control in people with prediabetes or type 2 diabetes within the next 12 months.
    • Pilot clinical study for additional products targeting indications such as NASH/NAFLD or chemotherapy induced mucositis are anticipated to start in second half of 2018.

     

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.



Proprietary Gelesis Platform



Efficacy & Safety Summary


~70% very strong appeal, with 90% of those likely to ask a doctor for Gelesis100*


Pipeline