Ascletis selects ASC36 for once-monthly obesity treatment

Ascletis Pharma Inc. is advancing ASC36, a subcutaneously administered amylin receptor agonist, into clinical development with an Investigational New Drug (IND) application expected to be submitted to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026. This compound is designed for once-monthly dosing, supported by preclinical data showing an average observed half-life of approximately 15 days in non-human primate (NHP) studies, which is three times longer than petrelintide.

In head-to-head diet-induced obese (DIO) rat studies, ASC36 demonstrated superior efficacy, achieving a 10.01% reduction in body weight compared to 5.25% for petrelintide, representing a 91% greater relative body weight reduction. This superior performance is expected to offer scalability advantages in manufacturing. Additionally, ASC36 exhibits excellent chemical and physical stability, allowing for co-formulation with other peptides such as ASC35, a GLP-1R/GIPR dual agonist, for potential combination therapies.

The company plans to develop ASC36 as a cornerstone therapy for cardio-metabolic diseases, including obesity, both as monotherapy and in combination with ASC35.