Ascletis Pharma IncIND submissions to FDA for obesity treatments ASC36 and ASC36_35 FDC, a regulatory step toward clinical trials.

Ascletis Pharma has submitted two Investigational New Drug applications to the U.S. FDA for its obesity treatment candidates ASC36 and ASC36_35 FDC. ASC36 is a once-monthly to once-quarterly peptide amylin receptor agonist, while ASC36_35 FDC is a once-monthly injection co-formulation of ASC36 plus the peptide GLP-1R/GIPR agonist ASC35. In preclinical diet-induced obesity rat studies, ASC36 monotherapy showed approximately 91% and 32% greater relative body weight reduction than petrelintide and eloralintide monotherapies, respectively, and ASC36_35 FDC demonstrated approximately 51% greater relative body weight reduction compared with co-administration of eloralintide and tirzepatide. The company's lead program, ASC30, is being evaluated for chronic weight management. Ascletis' stock was up 1.99% at HK$11.77.
Ascletis Pharma IncIND submissions to FDA for obesity treatments ASC36 and ASC36_35 FDC, a regulatory step toward clinical trials.