ASCLETIS-B (01672) selected the best in class once-monthly subcutaneous injection of insulin receptor agonist ASC36 to enter clinical development stage.

ASCLETIS-B (01672) announced that a monthly subcutaneous injection of amylin receptor agonist ASC36 has been selected as a clinical development candidate for potential treatment of obesity. Gellay is expected to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ASC36 for the treatment of obesity in the second quarter of 2026. ASC36 is a novel peptide amylin receptor agonist developed using Gellay's proprietary structure-based AI-assisted drug discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies. Through design optimization, ASC36 achieves a longer apparent half-life (time required for blood drug concentration to decrease by 50% of Cmax) and higher bioavailability per mg of peptide, supporting monthly subcutaneous dosing in a volume not exceeding 1 mL. These design-optimized characteristics result in lower costs in manufacturing scalability. In head-to-head studies in non-human primates, the average observed half-life of the depot formulation of ASC36 is approximately 15 days, three times longer than petrelintide, suggesting that ASC36 may be suitable for monthly dosing in humans for the treatment of obesity. In head-to-head studies in diet-induced obese (DIO) rats (a model shown to have high predictive value for efficacy in humans), ASC36 and petrelintide at equimolar concentrations resulted in weight loss of 10.01% and 5.25%, respectively, with ASC36 showing a 91% relative improvement in weight loss (Table 1). The superior weight loss effect per mg of peptide may also contribute to lower manufacturing costs for ASC36 on a large scale.