Ascletis Selects Its First Oral GLP-1R/GIPR/GCGR Triple Peptide Agonist, ASC37, for Clinical Development

Core Viewpoint - Ascletis Pharma Inc. has selected ASC37 oral tablets as a clinical development candidate for obesity treatment, leveraging its proprietary Peptide Oral Transport ENhancement Technology (POTENT) to achieve significantly higher oral bioavailability compared to existing treatments [4][5][6]. Group 1: Product Development - ASC37 oral tablets achieved an average absolute oral bioavailability of 4.2%, which is approximately 9-, 30-, and 60-fold higher than semaglutide, tirzepatide, and retatrutide, respectively, in head-to-head non-human primate (NHP) studies [6]. - The drug exposure of ASC37, measured by the area under the curve (AUC), was approximately 57-fold greater than that of retatrutide in NHP studies [2][6]. - The average observed half-life of ASC37 oral tablets was approximately 56 hours, supporting once daily and less frequent oral dosing [2][7]. Group 2: Clinical Development Timeline - The company plans to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for ASC37 oral tablets in the second quarter of 2026 [3][4]. - A conference call will be hosted by the company in Mandarin on December 1, 2025, to discuss further developments [3][9]. Group 3: Technological Innovation - ASC37 is developed using Ascletis' Artificial Intelligence-Assisted Structure-Based Drug Discovery (AISBDD) and is a GLP-1R, GIPR, and GCGR triple peptide agonist, demonstrating in vitro activity that is approximately 5-, 4-, and 4-fold more potent than retatrutide for GLP-1R, GIPR, and GCGR, respectively [5][8]. - The selection of ASC37 for clinical development highlights the company's strong R&D capabilities and commitment to addressing unmet needs in obesity treatment [8]. Group 4: Company Overview - Ascletis Pharma Inc. is a fully integrated biotechnology company focused on developing and commercializing therapeutics for metabolic diseases, utilizing proprietary technologies including AISBDD and POTENT [10]. - The company has developed multiple drug candidates, including ASC30, ASC36, ASC35, and ASC37, targeting chronic weight management [10].