Hong Kong-based Ascletis Pharma Inc (HKEX: 1672) has selected ASC35, a once-monthly, potentially best-in-class subcutaneously (SQ) administered GLP-1 receptor (GLP-1R)/GIP receptor (GIPR) dual peptide agonist, as a clinical development candidate, the company announced on Sunday.

Ascletis expects to submit an Investigational New Drug Application (IND) for ASC35 for the treatment of obesity to the US Food and Drug Administration (FDA) in the second quarter of 2026.

ASC35, a GLP-1R and GIPR dual peptide agonist, was discovered and developed in-house utilising Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies. According to the company, ASC35 was approximately 4-fold more potent than tirzepatide for both GLP-1R and GIPR in vitro.

ASC35 is being developed as a monotherapy and in combination for the treatment of cardio-metabolic diseases including obesity, diabetes and metabolic dysfunction-associated steatohepatitis (MASH). Ascletis plans to combine ASC35, a GLP-1R/GIPR dual agonist, with its ASC36, a once-monthly subcutaneously administered amylin receptor peptide agonist to treat obesity and diabetes. It also plans to combine ASC35 with its once-monthly SQ ASC47, an adipose-targeted thyroid hormone receptor beta (THR beta) agonist, to treat multiple metabolic diseases such as obesity and MASH.

Ascletis said that its AISBDD and ULAP technologies enable it to design, optimise and develop multiple once-monthly SQ ultra-long-acting peptides, including ASC35 and ASC36. Based on the properties of peptides, the company can design, through its proprietary ULAP technology, various slow-release constants (k) for peptides in SQ depots to precisely release injected peptides over desired dosing intervals to reduce peak-to-trough ratios and improve clinical outcomes.