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Glyscend Therapeutics Announces Preclinical Data at ADA 2021 on the Metabolic Benefits of its Oral Polymer-based Duodenal Exclusion Therapy

Glyscend Inc presented data during the American Diabetes Association 80th Scientific Sessions virtual meeting, June 25-29, 2021, from a study of its proprietary oral polymer duodenal exclusion therapy. The positive data were presented ahead of Glyscend's phase I clinical trials, which have commenced recruiting healthy subjects in South Australia.

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 type 2 diabetes (T2D). Glyscend's 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 novel synthetic polymers are inert, non-absorbed, and naturally eliminated through the GI tract within 24 hours.

The study evaluated the metabolic effects of its therapeutic (GLY-POL) in a non-obese T2D Goto-Kakizaki (GK) rat model, compared to control. Eight weeks of administering GLY-POL once daily resulted in a robust reduction in fasting plasma glucose and post-prandial glucose (PPG) as well as insulin resistance. Oral glucose tolerance testing performed after chronic GLY-POL therapy resulted in a profound reduction of PPG (incremental area under curve (iAUC) ? = 60 ? 70%) compared to control, with the reduction amplified with duration of therapy. Similar reduction in PPG iAUC was evident during mixed meal tolerance testing (iAUC ? > 55%), suggesting that oral, polymer-based duodenal exclusion therapy is a viable method of improving glucose homeostasis. The GLY-POL therapy, when given once a day, resulted in a 6% weight loss compared to control (p<0.005), without a difference in food intake between the groups.

"The technology we have developed was inspired by the remarkable efficacy of gastric bypass surgery in correcting the metabolic alterations associated with type 2 diabetes. However, these procedures will likely never scale to meet the burgeoning T2D epidemic, due to surgical risks, invasiveness, access, and high cost," stated Ashish Nimgaonkar, MD, President and CEO of Glyscend, and a gastroenterologist at The Johns Hopkins Hospital.

"Our goal is to develop an oral medication that works locally in the gastrointestinal tract to provide the benefits of gastric bypass surgery while greatly reducing the costs, as well as the potential risks and complications," according to Dr. Nimgaonkar.

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."

Glyscend is set to initiate the first-in-human trials to test the safety of its lead compound (GLY-200). The recruitment of healthy participants as part of the phase I study has initiated in Adelaide, South Australia.

Additional data will be presented as an oral presentation at the European Association for the Study of Diabetes (EASD) annual meeting in September, 2021.

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.

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