ASCLETIS-B (01672) announced that its monthly-dose next-generation amylin receptor agonist ASC36 and GLP-1R/GIPR dual-target agonist ASC35 combination therapy has entered clinical development. The company plans to submit an Investigational New Drug (IND) application to the U.S. FDA in Q2 2026 for this obesity treatment candidate.

Both ASC36 and ASC35 were independently developed by ASCLETIS using its AI-Assisted Structure-Based Drug Discovery (AISBDD) platform and Ultra-Long-Acting Platform (ULAP) technology. The proprietary ULAP technology enables the formulation of these compounds into a monthly subcutaneous injection.

The ASC36/ASC35 combo demonstrates superior physicochemical stability without pH-dependent fibril aggregation - a common issue with some amylin agonists that can reduce efficacy, cause turbidity/particles, device clogging, and higher immunogenicity risks.

Non-human primate studies showed comparable pharmacokinetics between the combo and individual drugs, supporting monthly dosing. In head-to-head diet-induced obesity (DIO) studies: - ASC36 monotherapy showed 32% greater weight loss than eloralintide in rats - ASC35 monotherapy demonstrated 71% superior efficacy versus tirzepatide in mice - The ASC36/ASC35 combination achieved 51% better weight reduction than eloralintide/tirzepatide combo in rats

"These compelling preclinical results suggest our combo could deliver significantly greater weight loss than monotherapies in obese patients," said Dr. Jinzi Wu, Founder, Chairman and CEO of ASCLETIS. "Our platform continues demonstrating its capability in designing and optimizing monthly-administered ultra-long-acting peptides."