Ascletis Selects a Best-In-Class Once-Monthly Subcutaneously Administered GLP-1R/GIPR Dual Peptide Agonist, ASC35, for Clinical Development

Core Insights - Ascletis Pharma Inc. has selected ASC35, a once-monthly GLP-1R/GIPR dual peptide agonist, as a clinical development candidate for obesity treatment, with an IND submission expected in Q2 2026 [2][3][4] Group 1: Drug Efficacy and Characteristics - ASC35 has an average observed half-life of approximately 14 days in non-human primate studies, which is 6-fold longer than tirzepatide, supporting its once-monthly subcutaneous dosing in humans [1][4] - In head-to-head studies, ASC35 demonstrated approximately 71% greater relative body weight reduction compared to tirzepatide in diet-induced obese mice, with ASC35 reducing body weight by 33.6% versus 19.6% for tirzepatide [1][5][7] - ASC35 is approximately 4-fold more potent than tirzepatide for both GLP-1R and GIPR in vitro, indicating its potential as a best-in-class treatment for obesity [1][4][7] Group 2: Development and Technology - ASC35 was developed using Ascletis' proprietary Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies, which allow for optimized drug design and manufacturing scalability [4][10] - The pharmacokinetic relationship established in non-human primates suggests that ASC35 may have a predicted half-life of 30 days or longer in humans, enhancing its therapeutic profile [4][7] - Ascletis plans to explore combination studies of ASC35 with other therapeutic candidates, including ASC36 and ASC47, to address multiple metabolic diseases [9] Group 3: Strategic Vision - The selection of ASC35 reflects Ascletis' commitment to innovation in the treatment of obesity and metabolic diseases, complementing its existing portfolio of small molecule candidates [8] - The company aims to provide a more versatile and patient-friendly titration schedule with ASC35's once-monthly dosing [8]