BOSTON--(BUSINESS WIRE)--Glyscend Therapeutics, a clinical-stage biopharmaceutical company advancing first-in-class oral polymeric drugs for the treatment of metabolic disease, today announced the initiation of a Phase 2 clinical trial of its lead candidate, GLY-200, as a novel oral treatment for obesity. GLY-200 previously demonstrated clinically meaningful reductions in fasting and postprandial glucose, fasting lipids, body weight, food intake, and appetite versus placebo in a completed two-week study in patients with type 2 diabetes and was also shown to be well-tolerated with no treatment-related safety signals. This ongoing Phase 2 trial is designed to evaluate the efficacy, safety, and tolerability of GLY-200 in a non-diabetic obese population.
Obesity and type 2 diabetes affect hundreds of millions of people who need well-tolerated and effective ways to manage their disease. While metabolic (bariatric) surgery is one such effective approach, it is an invasive and expensive procedure, limiting its therapeutic use and potential. In addition, while injectable incretin therapies are effective, they can have side effects that impact patients’ ability to stay on therapy long-term. Today, there remains a significant need for well-tolerated oral therapies with differentiated mechanisms that offer long-term efficacy alone and in combination with currently available options.
“Advancing GLY-200 into this Phase 2 obesity trial marks another major milestone for Glyscend as we seek to bring innovative oral therapies to patients with metabolic disease,” said Sapan Shah, Ph.D., chief executive officer of Glyscend. “Building on previous clinical data in patients with diabetes, we believe GLY-200 may also provide meaningful weight-loss benefit and a well-tolerated profile for patients with obesity. Given its unique mechanism of oral pharmacologic duodenal exclusion, GLY-200 has the potential to be complementary to existing treatments and could expand the therapeutic arsenal needed to treat the global obesity epidemic.”
GLY-200 is a first-in-class, orally administered, non-absorbed polymeric drug that was designed to target and enhance the natural mucus barrier of the duodenum in the upper small intestine. The duodenal epithelium acts as a nutrient sensing and metabolic signaling center and has been shown to undergo morphological changes and become dysfunctional in patients with metabolic disease, including obesity and type 2 diabetes. The enhanced mucus barrier in the duodenum created by GLY-200 is intended to restore and activate beneficial gut-mediated signaling through multiple downstream metabolic pathways, including enhanced release of GLP-1 and PYY, thereby reproducing many of the beneficial effects of bariatric surgery in a non-invasive oral pharmacologic duodenal exclusion approach.
In the ongoing 16-week Phase 2 clinical trial, approximately 70 participants with a BMI between 32 and 40 mg/kg2 will be randomized to receive either 2.0 g GLY-200 or placebo twice-daily for 16 weeks. The primary outcome measures will be percent change in body weight from baseline and the proportion of participants who achieve ≥ 5% body weight reduction at Week 16. Additional outcome measures include safety and tolerability, waist circumference, and glycemic and lipid parameters. Enrollment is underway at five sites across the US, and Glyscend anticipates results from the Phase 2 trial in the first quarter of 2025.
Additional trial details can be found by visiting ClinicalTrials.gov.
About Glyscend, Inc.
Glyscend Therapeutics is a clinical-stage biopharmaceutical company that is taking a novel approach to the treatment of metabolic disease, led by obesity and type 2 diabetes (T2D), with first-in-class oral polymeric drugs that have the potential to address significant unmet needs for patients globally. The company’s lead candidate, GLY-200, is designed to be non-absorbed and selectively target and bind to the mucus lining of the upper GI tract, where it can modulate nutrient sensing and downstream metabolic signaling pathways. Based on its unique mechanism of action, GLY-200 is intended to mimic the beneficial effects of metabolic surgery and duodenal exclusion devices. In a Phase 2a study in patients with T2D, GLY-200 was well-tolerated and demonstrated clinical proof-of-concept, with statistically significant improvements on glycemic control and body weight as well as potential beneficial effects on other metabolic markers. Glyscend plans to advance GLY-200 into longer term Phase 2b studies in patients with obesity and T2D. The company is backed by healthcare innovators, Santé Ventures and Brandon Capital Partners, and was founded based on research and funding from Johns Hopkins University, the Thiel Foundation and Breakout Labs. For more information, please visit www.glyscend.com.
