Glyscend Begins Phase 2 Obesity Trial with GLY-200 Drug Candidate

Glyscend Therapeutics, a clinical-stage biopharmaceutical company, has commenced a Phase 2 clinical trial for its leading candidate, GLY-200, aimed at treating obesity through an innovative oral therapy. This trial follows a successful two-week study that demonstrated significant reductions in fasting and postprandial glucose, fasting lipids, body weight, food intake, and appetite in type 2 diabetes patients, without any notable safety concerns.

Obesity and type 2 diabetes present major health challenges globally, affecting hundreds of millions of individuals who require effective and well-tolerated treatments. While bariatric surgery is an effective solution, it is invasive and costly, limiting its accessibility. Injectable incretin therapies, although beneficial, often come with side effects that make long-term adherence difficult for patients. This underscores the urgent need for oral treatments that offer sustained efficacy, either alone or in conjunction with existing therapies.

Sapan Shah, Ph.D., CEO of Glyscend, highlighted the significance of advancing GLY-200 into the Phase 2 obesity trial. "Building on our previous clinical data in diabetic patients, we believe GLY-200 can offer substantial weight-loss benefits and be well-tolerated by obese patients. Its unique oral pharmacologic duodenal exclusion mechanism positions it to complement current treatments, potentially expanding the options available to combat the global obesity crisis," Shah explained.

GLY-200 is an innovative, orally administered, non-absorbed polymeric drug specifically designed to target the duodenum’s natural mucus barrier in the upper small intestine. The duodenal epithelium plays a crucial role in nutrient sensing and metabolic signaling, often becoming dysfunctional in individuals with metabolic diseases like obesity and type 2 diabetes. By enhancing the mucus barrier, GLY-200 aims to restore and activate beneficial gut-mediated signaling pathways, such as the release of GLP-1 and PYY hormones, mimicking the positive effects of bariatric surgery through a non-invasive method.

The current Phase 2 trial spans 16 weeks and involves approximately 70 participants with a BMI between 32 and 40 mg/kg2. Participants are randomized to receive either 2.0 g of GLY-200 or a placebo twice daily for the duration of the trial. The primary outcomes measured will be the percent change in body weight from the baseline and the proportion of participants achieving at least a 5% reduction in body weight by week 16. Secondary outcomes include safety and tolerability, waist circumference, and various glycemic and lipid parameters. The trial is actively enrolling at five sites across the United States, with results anticipated in the first quarter of 2025.

Glyscend Therapeutics is dedicated to developing first-in-class oral polymeric drugs to address significant unmet needs in metabolic disease treatment, particularly obesity and type 2 diabetes. Their lead candidate, GLY-200, leverages a novel mechanism of action to offer potentially transformative benefits for patients. Supported by leading healthcare investors and founded on research from Johns Hopkins University, Glyscend is poised to make substantial contributions to the field of metabolic disease treatment.