The Board of ASCLETIS-B (01672) announced that it has selected ASC37, a next-generation, once-monthly, subcutaneously administered GLP-1R/GIPR/GCGR triple agonist peptide, as a clinical development candidate. The company expects to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for ASC37 in the treatment of obesity in the second quarter of 2026. ASC37 is a proprietary triple agonist peptide targeting GLP-1R, GIPR, and GCGR, developed using the company's structure-based AI-assisted drug discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies. In vitro studies demonstrated that ASC37 exhibits approximately 5 times, 4 times, and 4 times greater agonistic activity on GLP-1R, GIPR, and GCGR, respectively, compared to retatrutide. Through design optimization, ASC37 achieves a significantly longer observed half-life—the time for blood concentration to drop to 50% of Cmax—supporting a once-monthly subcutaneous dosing regimen with an injection volume not exceeding 1 milliliter, a notable improvement over the once-weekly retatrutide. These optimized design features also confer scalability advantages in manufacturing, leading to lower production costs. In a head-to-head study in non-human primates, ASC37's proprietary subcutaneous depot formulation exhibited an average observed half-life of approximately 17 days, which is about 7 times longer than that of retatrutide in a standard liquid formulation. ASC37's superior in vitro agonistic activity and extended half-life compared to retatrutide suggest its strong potential to become a next-generation therapy for obesity. "We are advancing ASC37, a next-generation triple agonist with the potential for enhanced efficacy and a convenient monthly dosing schedule, into the clinical stage," said Dr. Jinzi J. Wu, Founder, Chairman, and CEO of Ascletis. "Our Phase I study for this candidate is anticipated to commence in the second half of 2026, marking another strategic step forward in our comprehensive plan to improve treatment options for people with obesity." ASC37 is being developed both as a monotherapy and as part of combination therapies for cardiometabolic diseases, including obesity, diabetes, and metabolic dysfunction-associated steatohepatitis (MASH). The company plans to combine the GLP-1R/GIPR/GCGR triple agonist ASC37 with its once-monthly subcutaneous amylin receptor agonist peptide, ASC36, for the treatment of obesity, diabetes, and other metabolic disorders. Ascletis's AISBDD and ULAP technologies enable the design, optimization, and development of multiple once-monthly, subcutaneous, ultra-long-acting peptides, including ASC35, ASC36, and ASC37. Leveraging the properties of peptides, the company's proprietary ULAP technology can design various release rate constants (k) for peptides within a subcutaneous depot, enabling precise release over a pre-set dosing interval, which helps reduce peak-to-trough plasma concentration ratios and improve clinical efficacy.
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