Glyscend Therapeutics commences South Australia Phase I clinical trial to progress new type 2 diabetes treatment
August 3, 2021
Positive preclinical data suggests that Glyscend’s unique pill, mimicking gastric bypass surgery, will prove effective in treating type 2 diabetes
An orally administered type 2 diabetes (T2D) therapy, which could mirror the astonishing effect of gastric bypass surgery in improving sugar control in diabetes patients, will commence recruitment for a Phase I clinical trial in South Australia following promising pre-clinical study results.
The treatment, GLY-200, is a pill developed by Glyscend, a company spun out by researchers from The Johns Hopkins University Hospital, US, in collaboration with Professors Chris Rayner and Michael Horowitz, from the Centre of Research Excellence in Translating Nutritional Science to Good Health, based at the University of Adelaide and Royal Adelaide Hospital. The company has successfully demonstrated promising efficacy and a good safety profile in its pre-clinical studies, and it is now seeking 64 healthy volunteers for Phase I trials, commencing in August at CMAX in Adelaide.
Gastric bypass surgery works for many people with type 2 diabetes due to the diversion of intestinal contents away from the upper gastrointestinal tract. This, together with weight loss due to the lower amounts of calories entering the body, can put type 2 diabetes into remission. However, gastric bypass surgery is risky, costly, and invasive, limiting its adoption.
GLY-200 therapy mimics gastric bypass surgery in improving sugar control in patients with T2D by temporarily augmenting the natural mucus barrier lining in the upper gut and affecting hormonal signalling between the GI tract, liver, pancreas and brain. The treatment does not carry the same risks associated with the invasive surgery, offering hope to the one million Australians, or 500 million people globally, diagnosed with T2D, a chronic condition that effects the way the body processes blood sugar.
Thomas Jozefiak, PhD, Co-Founder and Chief Scientific Officer of Glyscend, said that “The results of our pre-clinical studies demonstrated that a daily dose of GLY-200 for 8 weeks significantly reduces the post-meal glucose measurements in diabetic rat models. This improvement was also associated with an improved metabolic profile and weight loss, without a difference in food intake.”
Ashish Nimgaonkar, MD, President and CEO of Glyscend, and a Physician at Johns Hopkins Hospital, says that these early results further solidify the goal of developing a safer alternative to managing T2D than gastric bypass surgery.
“This pill has the potential to revolutionise how we treat type 2 diabetes. We are excited to begin recruiting for healthy participants to take part in our clinical trial in South Australia. 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,” says Dr Nimgaonkar. “Gastric bypass procedures will likely never scale to meet the burgeoning T2D epidemic, due to surgical risks, invasiveness, access and compliance issues, and high cost.”
“The world class expertise and facilities, coupled with an attractive research and development ecosystem are why Glyscend intends to conduct our first-in-human trials in Adelaide,” says Dr Bob Soh, Director at Glyscend and Investment Manager at Brandon Capital Partners. “The research collaboration to date has been really successful, and we look forward to initiating our clinical trials in SA soon.”
In June 2020, Glyscend Therapeutics received AUD$29m Series A investment in a funding round led by Brandon Capital’s Medical Research Commercialisation Fund (MRCF) and US healthcare investor, Santé Ventures, with support from Breakout Labs, a fund in the Thiel Foundation, owned by PayPal cofounder Peter Thiel.
The Glyscend clinical trials are set to take place in the South Australian clinical trial site CMAX. Healthy volunteers interested in taking part in the clinical trial can find out more information here.
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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.