Policy & Regulation
Glyscend Therapeutics Completes Phase 1 Clinical Trial of its Oral, Gut-restricted, Polymer Therapeutic, GLY-200, as a Potential Type 2 Diabetes Treatment
11 May 2022 - - US-based biotechnology company Glyscend Therapeutics has completed a Phase 1 trial for its lead clinical-stage program, GLY-200, as a treatment for type 2 diabetes, the company said.

In addition, Glyscend announced the expansion of its leadership team with the appointment of Mark Fineman, Ph.D., a seasoned R and D leader in metabolic diseases, as chief development officer.

GLY-200 is a proprietary mucin-complexing polymer 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.

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 application to the US Food and Drug Administration and begin Phase 2 development in patients with T2D in mid-2022.

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.

Dr. Fineman is a recognized R and D leader who brings more than 30 years of industry experience to Glyscend, including a 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 and 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.
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