Glyscend Therapeutics Announces Completion of Phase 1 Clinical Trial of its Oral, Gut-restricted, Polymer Therapeutic, GLY-200, as a Potential Type 2 Diabetes Treatment

GLY-200 Well-Tolerated Across Doses Evaluated, Supporting Potential as First-in-class Treatment for Type 2 Diabetes and Related Metabolic and Chronic Conditions

Initiation of Phase 2 Trial for GLY-200 in Patients with Type 2 Diabetes Anticipated in Mid-2022

Company’s Expertise in Gastroenterology, Metabolism, and Polymer Chemistry Further Strengthened by Recent Appointment of Mark Fineman, Ph.D., as Chief Development Officer

BOSTON–(BUSINESS WIRE)–Glyscend Therapeutics, a clinical-stage biotechnology company pioneering a new generation of orally administered polymer therapies for metabolic and chronic conditions, today reported the completion of a Phase 1 trial for its lead clinical-stage program, GLY-200, as a treatment for type 2 diabetes (T2D). In addition, Glyscend announced the expansion of its leadership team with the appointment of Mark Fineman, Ph.D., a seasoned R&D leader in metabolic diseases, as Chief Development Officer.

GLY-200 is a proprietary mucin-complexing polymer (MCP) that enhances the natural mucus barrier in the duodenum (the upper small intestine). This enhanced barrier results in a pharmacologic ‘duodenal exclusion’ that may non-invasively and safely reproduce many of the beneficial effects of metabolic surgery in patients suffering from a variety of metabolic disorders, including T2D, while avoiding the complications associated with invasive surgeries and procedures.

“Metabolic surgery can lead to immediate and significant improvements in glycemic and lipid control, but its cost and risks continue to limit widespread use. Our goal at Glyscend is to leverage our proprietary MCP platform and extensive insights into gastrointestinal disease to build upon the disease-modifying effects of metabolic surgery,” said Ashish Nimgaonkar, M.D., President and Chief Executive Officer of Glyscend. “We aspire to replicate the profound effects of metabolic surgery with a safe, accessible, and affordable oral treatment for patients with metabolic conditions. Our clinical candidate, GLY-200, is optimized to treat patients with T2D and potentially reverse the course of disease. With the completion of the Phase 1 trial, we are excited to be preparing for an IND submission and initiation of Phase 2 development – making this the perfect time to welcome Mark Fineman to our team. Mark’s translational expertise and deep experience in driving metabolic disease R&D programs from early stages through launch will be invaluable to our future growth, and we are thrilled to have him on board.”

Glyscend’s single and multiple ascending dose (SAD/MAD) Phase 1 trial enrolled 64 healthy adult volunteers to evaluate the safety and tolerability of oral GLY-200. GLY-200 was well-tolerated across dose levels tested with no safety signals observed and no serious adverse events reported. Mild dose-dependent gastrointestinal symptoms were the only common adverse events observed. Based on these findings, Glyscend plans to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration and begin Phase 2 development in patients with T2D in mid-2022.

Dr. Fineman added, “The GI tract has long been recognized as a major player in metabolic regulation due to its role in modulating signaling between the gut, liver, and brain. At Glyscend, we have curated an expansive library of novel non-absorbed polymers that are pH-responsive and tunable to different regions of the gut, giving them the potential to alter gut wall behavior and treat a range of gastrointestinal and metabolic diseases. Given the non-absorbed properties of our polymers, we believe our approach is safety advantaged and poised to deliver an entirely new and game-changing class of therapeutics. With the completion of our Phase 1 trial for our lead program, we look forward to further advancing our pipeline to benefit patients in need.”

In parallel to its drug development efforts focused initially on metabolic diseases such as T2D and obesity, Glyscend is applying its MCP platform to expand its pipeline to include programs that address topical GI as well as systemic, inflammatory, and autoimmune conditions. The company is studying additional applications of its technology including use in polymer-drug conjugates for novel GI tract targets and to enhance the bioavailability of oral peptide therapies.

Mark Fineman, Ph.D., Chief Development Officer

Dr. Fineman is a recognized R&D leader who brings more than 30 years of industry experience to Glyscend, including the leadership of teams through development, approval, and commercialization of three first-in-class diabetes medicines: Byetta®, the first GLP-1 agonist, Bydureon®, the first once-weekly GLP-1 agonist, and Symlin®, the first non-insulin treatment indicated for Type 1 diabetes. Dr. Fineman also led the development of several early- and mid-stage programs in diabetes, obesity, osteoarthritis, neurodegenerative disease, psychiatric disease, lipodystrophy, and wound healing compounds. He joins Glyscend from Biosplice Therapeutics where he was Senior Vice President, Clinical Affairs. At Elcelyx Therapeutics, he served as Chief Scientific Officer and led the development of minimally absorbed novel pharmaceutical and consumer products that target intestinal L cells to enhance secretion of gut hormones, including a program for the treatment of T2D patients with late-stage renal disease. Dr. Fineman held roles of increasing responsibility at Amylin for 20 years, reaching Executive Director of Medical Development and R&D Strategic Relations. Dr. Fineman received his Ph.D. in Medical Research from Vrije Universiteit, Amsterdam and his M.S. in Molecular Pathology and M.A.S. in Clinical Research from the University of California, San Diego.

About Type 2 Diabetes

Type 2 Diabetes (T2D) affects approximately 500 million people worldwide and is characterized by complex metabolic dysfunctions resulting in high morbidity and mortality and significant treatment costs. The current standard of care begins with lifestyle alterations and escalates through oral drugs, injected medications, insulin, and, in a select few, metabolic surgery. Despite the many therapeutic options, nearly half of T2D patients continue to exhibit uncontrolled diabetes. Moreover, none of the currently available therapies are considered disease-modifying, with the exception of metabolic surgery, which involves surgical exclusion of the first part of the small intestine (the duodenum) and bypass of nutrient absorption in that region. Of all therapeutic interventions for T2D, metabolic surgery has shown the most immediate and profound effects on improving blood glucose and body weight, with longer-term reductions in microvascular complications related to T2D. However, while effective, a limited number of patients qualify for metabolic surgery due to its invasiveness and cost.

About Glyscend, Inc.

Glyscend Therapeutics is a venture-backed, clinical-stage biopharmaceutical company developing novel orally administered, polymer therapies that work on targets inside the GI tract to treat a variety of metabolic and chronic disorders. Polymer-based therapies are a unique class of therapeutics with more than three decades of clinical experience in a wide range of applications. Glyscend’s polymer technology platform evolved out of research at Johns Hopkins University where scientists were evaluating the mechanisms that result in significantly improved glucose and metabolic regulation that precedes weight loss in certain types of metabolic surgery. The company’s lead program is GLY-200 for the treatment of Type 2 diabetes (T2D). GLY-200 is a proprietary MCP that enhances the natural mucus barrier in the duodenum (the upper small intestine) targeting the mechanism of duodenal exclusion, which is a key aspect of metabolic surgery. GLY-200 was well-tolerated in a completed Phase 1 trial and is being advanced into Phase 2 development for patients with T2D. In addition, Glyscend is exploring program opportunities that address topical GI as well as systemic, inflammatory, and autoimmune conditions. The company is also investigating its technology to unlock novel GI tract targets using polymer-drug conjugates and to enhance the bioavailability of oral peptide therapies. For more information, please visit www.glyscend.com.

Contacts

Monique Allaire

THRUST Strategic Communications

[email protected]