Ascletis-B (01672) selected its first oral GLP-1R/GIPR/GCGR triple-target peptide agonist ASC37 for clinical development.

ASCLETIS-B(01672) announced that it has selected its first oral GLP-1R/GIPR/GCGR triple-target agonist peptide ASC37 oral tablet as a clinical development candidate drug. Gelei is expected to submit an Investigational New Drug Application (IND) for ASC37 oral tablets for the treatment of obesity to the U.S. Food and Drug Administration (FDA) in the second quarter of 2026. ASC37 oral tablet is the company's first incretin candidate drug developed using its proprietary Peptide Oral Transport Enhancement Technology (POTENT). ASC37 is a GLP-1R, GIPR, and GCGR triple-target agonist peptide discovered and optimized independently by Gelei using AI-assisted structure-based drug discovery technology. In vitro experiments have shown that ASC37 is about 5 times stronger in activating GLP-1R, 4 times stronger in activating GIPR, and 4 times stronger in activating GCGR compared to retatrutide. In head-to-head studies in non-human primates, using Gelei's POTENT technology, the average absolute oral bioavailability of ASC37 oral tablets is 4.2%, which is approximately 9 times, 30 times, and 60 times higher than semaglutide, tirzepatide, and retatrutide with oral SNAC formulation technology, respectively. Additionally, in head-to-head studies in non-human primates, after oral administration, the exposure of ASC37 oral tablets (POTENT formulation) in terms of drug exposure (measured by area under the curve (AUC)) is approximately 57 times higher than that of retatrutide (oral SNAC formulation). The average apparent half-life of ASC37 oral tablets in non-human primate studies is approximately 56 hours, supporting once daily or even less frequent oral dosing. "Selecting ASC37, a promising oral GLP-1R/GIPR/GCGR triple-target agonist peptide, for clinical development once again confirms our strong R&D capabilities and demonstrates our firm commitment to addressing the unmet needs in the field of obesity treatment," said Dr. Wu Jinzi, founder, chairman, and CEO of Gelei. "By leveraging our proprietary technology platforms such as AISBDD and POTENT, Gelei has successfully established a highly competitive, differentiated, and diversified pipeline combination that is expected to effectively address the various treatment needs of patients with obesity and other metabolic diseases."