Ascletis Pharma has initiated two Phase I studies in the United States evaluating investigational once-monthly injectable therapies for obesity.
The clinical programmes cover ASC36, a peptide amylin receptor agonist, and ASC36_35 FDC, a fixed-dose co-formulation combining ASC36 with ASC35, a peptide GLP-1R/GIPR agonist.
Both candidates form part of Ascletis’ expanding pipeline of long-acting therapies targeting metabolic disease.
ASC36 is being developed as a long-acting amylin receptor agonist using Ascletis’ ultra-long-acting drug development platform.
The company is also developing ASC36_35 FDC as a multi-mechanism obesity therapy targeting the amylin receptor, GLP-1 receptor and GIP receptor within a single monthly formulation.
Ascletis previously submitted investigational new drug applications to the US Food and Drug Administration for both programmes after completing preclinical development.
In preclinical diet-induced obesity models, the company reported that ASC36_35 FDC produced greater weight reduction than the combination of eloralintide and tirzepatide.
ASC36 was also evaluated against other investigational amylin-targeting therapies during preclinical development.
The two Phase I studies will provide initial clinical information on the candidates as Ascletis advances its portfolio of longer-acting obesity treatments.
Ascletis is also developing other metabolic disease candidates targeting GLP-1, GIP and glucagon-related pathways.
