Glyscend Therapeutics Announces Initiation of Phase 1 Clinical Trial on the Heels of Preclinical Data Presented at EASD 2021 on the Metabolic Benefits of its Oral Polymer-based Duodenal Exclusion Therapy

Phase 1 clinical trial currently underway in Australia investigating a noninvasive, oral polymer therapy that dramatically improves glucose homeostasis with weight loss in nonclinical models.

Excerpt from the Press Release:

BALTIMORE & BOSTON–(BUSINESS WIRE)–Glyscend, Inc. delivered an oral presentation highlighting preclinical data from a study of its oral proprietary polymer duodenal exclusion therapy during the 57^th Annual Meeting of the European Association for the Study of Diabetes on September 28, 2021. Data from earlier results were presented previously this year at the American Diabetes Association 80th Scientific Sessions. Glyscend has also been selected to present at the Obesity Society Annual Meeting in November 2021, focusing on the role of polymer-based duodenal exclusion therapy as an alternative to gastric bypass surgery for the management of obesity.

Glyscend is developing a new class of oral gut-restricted therapies targeting mechanisms underlying bariatric surgery and validated by endoscopic approaches, which have shown to be beneficial in treating Type 2 diabetes (T2D). The therapy is intended to temporarily augment the natural mucus barrier lining in specific portions of the GI tract and affect hormonal signaling via the gut-liver-brain axis. The synthetic, inert, nonabsorbable polymer is then naturally eliminated via the GI tract within 24 hours.

The preclinical study results presented at EASD 2021 evaluated the metabolic effects of once-daily oral therapy in an obese T2D Zucker Diabetic Fatty (ZDF) rat model over 8 weeks. This study showed a statistically significant (p<0.0001) reduction in peak post-prandial glucose after chronic treatment, with simultaneously decreased early peak insulin levels. A separate 8-week study in a lean T2D Goto-Kakizaki (GK) rat model with once daily oral therapy resulted in a similar profound reduction in post-prandial glucose (PPG) along with improvement in insulin resistance. There was significant weight loss without difference in food intake and no safety signals were observed. This promising preclinical package in well -validated models of T2D provides strong evidence that oral, polymer-based duodenal exclusion therapy is a viable method of improving glucose homeostasis and provided the impetus for a first-in-human trial initiated recently in South Australia in collaboration with Professors Chris Rayner and Michael Horowitz.

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