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.

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.

According to Ashish Nimgaonkar, MD, President and CEO of Glyscend, “Our technology was inspired by the remarkable efficacy of gastric bypass surgery in correcting the metabolic alterations associated with Type 2 diabetes. However, gastric bypass will likely never fully scale due to surgical risks, degree of invasiveness, access, and cost considerations. Therefore, our goal is to develop an oral medication that works locally in the GI tract and provides the benefits of surgery while greatly reducing the cost, risks, and potential complications.”

Thomas Jozefiak, PhD, Co-Founder and Chief Scientific Officer of Glyscend noted that “While the data confirm a key role for chronic duodenal exclusion in restoring glucose homeostasis, ongoing research and development continue to provide further understanding of the impact that polymer science can play in shaping future therapies in the metabolic disease space.”

In June 2020, Glyscend Therapeutics received US$20.5M Series A investment in a funding round led by Santé Ventures and Australia’s Brandon Capital through its Medical Research Commercialization Fund (MRCF) with support from Breakout Labs, a fund in the Thiel Foundation.

About Glyscend, Inc.

Glyscend Therapeutics is a venture-backed biopharmaceutical company developing novel orally-delivered compounds that work on targets inside the GI tract to treat a variety of metabolic disorders, including T2D. Glyscend’s polymer technology platform evolved from research at Johns Hopkins University, where scientists were evaluating the mechanisms that result in significantly improved glucose and metabolic regulation following certain types of bariatric surgery. Glyscend’s technology was invented through research that originated at Johns Hopkins University and was licensed from the University. The company is headquartered in Baltimore, MD, and performs materials science R&D at JLABS @ M2D2 in Lowell, MA. For more information, please visit www.glyscend.com.

About Glyscend’s Polymer-based Therapy

Glyscend’s patient-friendly, orally administered polymer therapy is intended to work locally in the GI tract by temporarily augmenting the natural mucus barrier lining in specific portions of the intestine. This barrier would alter food uptake in those portions of intestine to induce dramatic changes in hormonal signaling via the gut-liver-brain axis. Glyscend aims to replicate the beneficial effects of bariatric surgery via the “duodenal exclusion” mechanism, without the need for surgery. The duodenal exclusion mechanism has been well validated via other invasive endoscopic approaches. Bariatric surgery has been shown to have immediate and profound effects on improving blood glucose while reducing body weight and reducing long-term micro- and macro-vascular complications related to T2D. Glyscend’s technology could enable, not just the treatment but potentially a reversal of T2D. Glyscend’s novel synthetic polymers are inert, non-absorbed, and naturally eliminated through the GI tract within 24 hours. Polymer-based therapies are a proven unique class of therapeutics with more than three decades of clinical experience in a wide range of applications. Ongoing research and development continue to provide further understanding of the impact that polymer science can play in shaping future therapies in the metabolic disease space.

Contacts

Jill Shuman

Glyscend, Inc.

617-584-8595;

[email protected]