PureTech Regulatory News (PRTC)

21 March 2019

PureTech Health plc

PureTech's Affiliate Gelesis Announces Three Presentations at Endocrine Society Annual Meeting

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 deliver three poster presentations around its proprietary hydrogel platform at the Endocrine Society Annual Meeting (ENDO) in New Orleans from 23-26 March.

Eric Elenko, PhD, chief innovation officer at PureTech Health, said: "We're proud of Gelesis' strong presence at The Endocrine Society Annual Meeting, one of the premiere forums for scientific exchange around obesity and metabolic disorders. These three posters provide additional support for the therapeutic potential of the Gelesis platform across a range of conditions."

The full text announcement from Gelesis is as follows:

Gelesis Announces Three Presentations at Annual Endocrine Society Meeting

BOSTON, March 21, 2019 - Gelesis, a biotechnology company developing first-in-class mechanotherapeutics to treat obesity and other chronic diseases related to the gastrointestinal (GI) tract, today announced the Company will deliver three poster presentations at ENDO, the Endocrine Society Annual Meeting, held in New Orleans from March 23-26.

Two of the presentations will share expanded clinical data from the pivotal study of Gelesis100, an oral, non-systemic approach to weight loss. A third will highlight preclinical data suggesting a different product candidate derived from Gelesis' proprietary hydrogel platform can restore gut barrier function in mice with severe gut wall injury.

"We are pleased to share expanded clinical data which seeks to address crucial public health issues associated with overweight and obesity. We are also excited to present our latest research on leveraging our hydrogel technology in chronic diseases of the GI system," said Harry L. Leider, MD, MBA, FACPE, Chief Medical Officer of Gelesis. "We look forward to discussing our findings with the scientific community."

Details of the presentations are as follows:

Poster Title: Gelesis100 Reduces Insulin Resistance in Patients Who Are Overweight or Have Obesity with High Insulin Resistance: Results of the GLOW Study

Poster Session: P50. Obesity Mechanisms and Treatments PotpourriDate and Time: March 25, 2019, (1:00 - 3:00 PM)

Poster Location: Poster Board #MON-112, ENDO Expo Hall, Ernest N. Morial Convention Center

Poster Title: Elevated Fasting Plasma Glucose Predicts Higher Odds for Becoming a Super-Responder with Gelesis100 in the GLOW Pivotal Weight-Loss Study

Poster Session: P05. Obesity Comorbidities and TherapiesDate and Time: Saturday, March 23, 2019 (1:00 - 3:00 PM)

Poster Location: Poster Board # SAT-LB023, ENDO Expo Hall, Ernest N. Morial Convention Center

Poster Title: Gelesis Novel, Non-Systemic, Superabsorbent Hydrogel Improves Intestinal Barrier Function in Intestinal Injury Pre-Clinical Model

Poster Session: P50. Obesity Mechanisms and Treatments PotpourriDate and Time: Monday, March 25, 2019 (1:00 - 3:00 PM)

Poster Location: Poster Board # MON-LB022, ENDO Expo Hall, Ernest N. Morial Convention Center

About Gelesis 100

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. 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. Gelesis100 is pending De Novo clearance and is not available for sale in the United States.

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 (LSE: PRTC), 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 BIG medicines for dysfunctions of the Brain-Immune-Gut axis. The Company has gained deep insights into the connection between these systems and the resulting role in diseases that 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 with an unbiased, non-binary, and capital efficient R&D model across its affiliates and its internal labs. PureTech's affiliates include seven clinical-stage platforms with two product candidates that have been filed with the US Food and Drug Administration (FDA) for review and other novel pre-clinical programmes. The PureTech Health pipeline includes ground-breaking platforms and therapeutic candidates that were developed in collaboration with some of the world's leading experts.

PureTech's internal research and development is centred on tissue-selective immunomodulation for the treatment of oncology, autoimmune, and CNS-related disorders, with a near-term focus on targeting newly-discovered, foundational immunosuppressive mechanisms in oncology and novel approaches that harness the lymphatic infrastructure.

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

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