BOSTON--(BUSINESS WIRE)--Gelesis, a biotechnology company developing first-in-class mechanotherapeutics to treat chronic diseases related to the gastrointestinal (GI) pathway, today announced that it has closed a $30 million financing round. The proceeds from the financing will be used to support commercial-stage manufacturing, product launch preparations, company operations, and clinical advancement of the Company’s pipeline of additional product candidates for gastrointestinal disorders, including Type 2 diabetes and non-alcoholic steatohepatitis/non-alcoholic fatty liver disease (NASH/NAFLD). The Company also plans to submit Gelesis100 for regulatory approvals in the US and Europe in 2018.
"We look forward to submitting Gelesis100 for regulatory approvals. If approved by US and European regulatory authorities, we believe that Gelesis100 would be the first and only oral prescription of its kind designed to act mechanically in the GI system to help people achieve clinically meaningful weight loss,” said David Pass, PharmD, Chief Operating Officer and Head of Commercial at Gelesis. “In quantitative research evaluating the pivotal study results with over 600 people struggling to manage their weight, more than 70% found Gelesis100 extremely or very appealing based on its clinically proven efficacy and strong safety profile, and over 90% of these people were likely to ask their doctor for the product. Additionally, of over 200 clinicians polled, 79% of obesity specialists and 63% of primary care physicians stated that they were extremely or very likely to prescribe the product if asked.”
Gelesis100 is a new approach to weight loss that is designed to employ multiple mechanisms of action along the GI tract to promote satiety and induce weight loss. Gelesis100 is non-systemic and administered orally in capsules containing small hydrogel particles, which are made from two natural components that form a novel 3D structure. The novel hydrogel is manufactured through Gelesis’ multi-step, proprietary process and protected by 9 families of patents through 2033, several of which have already been allowed or issued in major markets.
Gelesis100 capsules are taken with water prior to a meal, after which the small hydrogel particles are released from the capsules in the stomach and rapidly absorb water, hydrating to approximately 100 times their original size. Gelesis100 is designed to mix homogeneously with food and travel through the GI tract inducing satiety, reducing hunger, and causing weight loss. Once in the large intestine, Gelesis100 releases most of the water, which is reabsorbed by the body. The small gel particles pass through the body without being absorbed and are safely eliminated in the same manner as food.
Gelesis100 has been studied in more than 500 patients across five clinical studies throughout the United States, Canada, and Europe and has shown weight loss, increased satiety, reduced hunger, and a consistently strong safety profile.
Gelesis is developing a novel mechanobiology platform 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 safely and effectively. In September 2017, Gelesis completed a pivotal trial for weight loss evaluating its lead product candidate Gelesis100. Additionally, Gelesis is conducting a proof-of-concept study for its second candidate, Gelesis200, which is optimized for weight loss and glycemic control in patients with type 2 diabetes and prediabetes. New hydrogel compositions based on the Gelesis mechanobiology platform technology are also being explored through an expanded pipeline with preclinical studies in other GI-related conditions such as non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH) and intestinal mucositis.
The Gelesis executive and advisory team includes some of the world’s leading experts in obesity, chronic disease research, and clinical development, as well as materials science innovators, commercialization experts, and entrepreneurs. Gelesis is an affiliate of PureTech Health (PRTC.L), an advanced, clinical-stage biopharmaceutical company. For more information, visit www.gelesis.com or connect with us on Twitter @GelesisInc.
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. 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.