Approximately 462 million individuals, constituting 6.3% of the global population, suffer from type 2 diabetes (T2D). This condition places them at heightened risk for heart disease, stroke, kidney dysfunction, ocular complications, dental issues, nerve impairment, and foot ailments. Gastric bypass surgery, known as bariatric surgery, has emerged as a transformative measure that immediately normalizes blood glucose levels while reducing body weight. Moreover, it cuts down the long-term incidence of both micro- and macro-vascular complications stemming from T2D. Despite its impressive efficacy, surgical and endoscopic procedures remain largely out of reach for a substantial portion of diabetes and obesity patients. Their invasiveness, associated complications, and substantial costs restrict the access of eligible candidates to these interventions. Now, a new pill that appears to mimic the effects of gastric bypass surgery provides fresh hope for people with T2D and obesity.

Glyscend Therapeutics’ (Lowell, MA, USA) lead product candidate, GLY-200 is the first of its kind orally administered agent designed to address both obesity and T2D through mechanisms that mirror the outcomes of metabolic surgery and duodenal exclusion devices. GLY-200's development revolves around modulating the mucosal barrier within the gastrointestinal (GI) tract, thus harnessing the therapeutic advantages of gastric bypass surgery without the need for invasive procedures. Capitalizing on Glyscend's proprietary polymer, GLY-200 establishes an interaction with the mucus membrane in the duodenum, thereby forming a dynamic barrier that prevents direct contact between ingested food and the mucosal lining of the duodenum.

Glyscend has conducted rigorous preclinical studies that support the safety and effectiveness of its compounds using relevant animal models of T2D and obesity. Recent safety and pharmacodynamic data from the Phase 1 trial of GLY-200, the first of its kind in humans, demonstrate that it mimics the biomarker signature witnessed with metabolic surgery. Encouragingly, the treatment demonstrated a safety profile marked by the absence of safety signals, serious adverse events, or dose-restricting toxicities. Any adverse effects were mild to moderate and dose-dependent, implying the likelihood of GLY-200's safety and general tolerability at dosages equal to or less than 2.0 g twice daily. The pharmacodynamic findings were in line with the biomarker characteristics linked to Roux-en-Y gastric bypass surgery and duodenal exclusion device, marking the first clinical demonstration of the possibility of duodenal exclusion using an orally administered drug.

“We are highly encouraged to see the acute clinical benefits of our orally administered first-in-class drug. The totality of the data on GLY-200 suggest it has the potential to replicate the mechanism of surgery and provide a non-invasive alternative to today’s invasive approaches,” said Dr. Mark Fineman, Glyscend’s Chief Development Officer. 

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