Gelesis to Present Full Data for Lead Candidate

RNS Number : 2651G

PureTech Health PLC

05 November 2018

 

5 November 2018

PureTech plc

PureTech's Gelesis to Present Expanded Pivotal Data for Lead Product Candidate at ObesityWeek 2018

PureTech Health plc (LSE: PRTC) ("PureTech Health"), an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) Axis, today announced that its affiliate, Gelesis, will present expanded data from the pivotal study of Gelesis100, its lead investigational product candidate for weight loss. The data will be presented at ObesityWeek 2018, the annual combined congress of the American Society for Metabolic and Bariatric Surgery and The Obesity Society in Nashville, Tennessee, from 11-15 November 2018.

Eric Elenko, PhD, Chief of Research and Strategy at PureTech Health, said: "We are looking forward to Gelesis' strong presence at ObesityWeek 2018, the preeminent forum that brings together world-renowned experts in obesity to share innovation and breakthroughs in science. The expanded data from the pivotal study of lead product candidate, Gelesis100, will provide additional insights around the potential for this exciting new approach to weight loss."

The full text announcement from Gelesis is as follows:

Gelesis Announces Presentations of Expanded Pivotal Data at ObesityWeek 2018

BOSTON, Nov. 5, 2018 - Gelesis, a biotechnology company developing first-in-class mechanotherapeutics to treat obesity and other chronic diseases related to the gastrointestinal (GI) tract, today announced that the Company will deliver an oral presentation and three poster presentations at ObesityWeek 2018, the annual combined congress of the American Society for Metabolic and Bariatric Surgery and The Obesity Society in Nashville, Tennessee, from November 11-15, 2018. The presentations will share data from the pivotal study of Gelesis100, an oral, non-systemic approach to weight loss, including data regarding early predictors of clinically meaningful weight loss.

"We are pleased to be able to present key clinical data from the pivotal study of our lead investigational product for weight loss, Gelesis100," said Harry L. Leider, MD, MBA, FACPE, Chief Medical Officer of Gelesis. "There is a tremendous need for new approaches to address overweight and obesity, and we look forward to participating in the preeminent scientific exchange around this disease that affects more than 130 million Americans."

Details of the presentations are as follows:

Monday, November 12, 2018: 1:15pm ET-2:45pm ET, Innovative Emerging Pharmacotherapy and Devices Forum

·     Clinical Potential of a Novel Superabsorbent Hydrogel Technology Platform; Elaine Chiquette, PharmD, Chief Scientific Officer, Gelesis

Wednesday, November 14, 2018: 12:00pm ET-1:30pm ET, poster presentations

·     Non-Systemic, Orally-Administered Hydrogel (Gelesis100) in Overweight or Obesity: Pivotal GLOW Study; Frank L. Greenway, MD, Medical Director and Professor at the Pennington Biomedical Research Center, Louisiana State University System (T-P-3267)

·     Early Weight Loss With Gelesis100 Predicts Clinically Significant Weight Loss in the GLOW Study; Louis J. Aronne, MD, FACP, Sanford I. Weill Professor of Metabolic Research, Weill-Cornell Medical College (T-P-3268)

·     Impact of Gelesis100 on Insulin Resistance in Overweight or Obesity in the GLOW Study; Ken Fujioka, MD, Director of the Nutrition and Metabolic Research Center and the Center for Weight Management, Scripps Clinic (T-P-3353)

About Gelesis100

Gelesis100 is a non-systemic, superabsorbent hydrogel in development for the potential treatment of overweight or obesity. It is made from two naturally derived building blocks, modified cellulose cross-linked with citric acid, that create a three-dimensional matrix. Orally administered in capsules with water before a meal, Gelesis100 particles rapidly absorb water in the stomach and homogenously mix with ingested foods. When hydrated, Gelesis100 occupies about one-fourth of the average stomach volume. Rather than forming one large mass, it creates thousands of small individual gel pieces with the elasticity (firmness) of solid ingested foods (e.g., vegetables) without caloric value. Gelesis100 maintains its three-dimensional structure and mechanical properties during transit through the small intestine. Once it arrives in the large intestine, the hydrogel is partially broken down by enzymes and loses its three-dimensional structure along with most of its absorption capacity. The released water is reabsorbed in the large intestine, and the remaining cellulosic material is expelled in the faeces. Gelesis100 is considered a medical device because it achieves its primary intended purpose through mechanical modes of action consistent with mechanobiology constructs. Gelesis100 received a Non-Significant Risk (NSR) designation by the FDA.

This investigational product has been studied in more than 450 patients (excluding patients treated by placebo) across five clinical studies throughout the United States, Canada, and Europe and in these studies has shown weight loss, increased satiety, and reduced hunger. Other than an increase in overall gastrointestinal adverse events (AEs), most of which were assessed as mild, there was no difference in the incidence and severity of AEs between the Gelesis100 and placebo groups. In both treatment groups, most AEs were mild or moderate in intensity. No serious adverse events were observed in the Gelesis100 group.

About Gelesis

Gelesis is developing a novel mechanobiology platform technology 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. In September 2017, Gelesis completed a pivotal trial for weight loss evaluating its lead investigational product candidate Gelesis100. Additionally, Gelesis is conducting a proof-of-concept study for its second candidate, Gelesis200, which is optimised for weight loss and glycaemic control in patients with type 2 diabetes and prediabetes. Novel hydrogel mechanotherapeutics based on the Gelesis platform technology are also being advanced through a pipeline with preclinical studies in other GI-related conditions such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), and inflammatory bowel disease (IBD).

The Gelesis executive and advisory team includes some of the world's leading experts in obesity, chronic disease research, and materials science. Gelesis was co-founded by PureTech Health (PRTC.L), an advanced, clinical-stage biopharmaceutical company. For more information, visit www.gelesis.com or connect with us on Twitter @GelesisInc.

About PureTech Health

PureTech Health (LSE: PRTC) is an advanced biopharmaceutical company developing novel medicines for dysfunctions of the Brain-Immune-Gut (BIG) Axis. The Company has developed deep insights into the connection between the individual components of these systems and the resulting role in many chronic diseases, which have proven resistant to established therapeutic approaches. By harnessing this emerging field of human biology, PureTech Health is developing new categories of medicines with the potential to have great impact on people with serious diseases.

PureTech Health is advancing a rich pipeline of innovative therapies across two divisions: the Affiliates division and the Internal division. Its Affiliates division includes two product candidates that have been filed with the US Food and Drug Administration (FDA) for review and several other novel clinical and pre-clinical programmes. These affiliates are developing ground-breaking platforms and therapeutic candidates in collaboration with some of the world's leading experts.

PureTech's Internal division is advancing a pipeline fuelled by recent discoveries in lymphatics and immune cell trafficking to modulate disease in a tissue-specific manner. These programmes leverage the transport and biodistribution of various immune system components for the targeted treatment of diseases with major unmet needs, including cancers, autoimmune diseases, and neuroimmune disorders.

For more information, visit www.puretechhealth.com or connect with us on Twitter @puretechh.

Forward Looking Statement

This press release contains statements that are or may be forward-looking statements, including statements that relate to the company's future prospects, developments and strategies. The forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results, performance and achievements to differ materially from current expectations, including, but not limited to, those risks and uncertainties described in the risk factors included in the regulatory filings for PureTech Health plc. These forward-looking statements are based on assumptions regarding the present and future business strategies of the company and the environment in which it will operate in the future. Each forward-looking statement speaks only as at the date of this press release. Except as required by law and regulatory requirements, neither the company nor any other party intends to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:

Investors	EU media	US media
Allison Mead Talbot [phone] [e-mail]	Ben Atwell, Rob Winder [phone] [e-mail]	Tom Donovan [phone] [e-mail]

 

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