|
Ascletis Pharma Inc. announces that it has selected ASC30_39 FDC, a fixed-dose combination (FDC) of ASC30, once-daily oral small molecule GLP-1R agonist and ASC39, once-daily oral small molecule amylin-selective amylin receptor agonist, for clinical development. Ascletis expects to submit an Investigational New Drug Application (IND) to the US Food and Drug Administration (FDA) for ASC30_39 FDC oral tablets for the treatment of obesity in the third quarter of 2026.
ASC30_39 FDC tablets, dosed orally in dogs, demonstrated excellent oral bioavailability, high drug exposure and a long half-life of up to 12 hours. These key parameters of ASC30_39 FDC tablets are consistent with those observed in their respective monotherapies in a head-to-head dog study. Furthermore, ASC30_39 FDC tablets, developed utilizing Ascletis’ proprietary formulation technology, demonstrated a good compatibility between ASC30 and ASC39 with room temperature stability and a small pill size. The combination of the excellent pharmacokinetic profile of ASC30_39 FDC, the potential best- in-class efficacy and gastrointestinal (GI) tolerability of ASC30 and the first eloralintide-like small molecule amylin support ASC30_39 FDC tablets as a potential novel one-pill-once-daily therapy for the treatment of obesity.
ASC30 is a phase III-ready oral small molecule GLP-1R agonist that had a favourable gastrointestinal (GI) profile with half the rate of vomiting vs. orforglipron, when both drugs are dosed with weekly titration in non-head-to-head studies.
As a clinical development candidate, ASC39 is a potent and amylin-selective oral small molecule amylin receptor agonist and demonstrated eloralintide-like amylin selectivity and efficacy in preclinical models.
“Selection of this fixed dose combination, which we believe is the first publicly announced co-formulation of an oral GLP-1 and an oral amylin, is an important step in the development of a new oral, potentially synergistic combination of ASC30 and ASC39 for the treatment of obesity,” said Jinzi Jason Wu, Ph.D., founder, chairman and CEO of Ascletis. “We believe this fixed dose combination, which combines the key features of high bioavailability, high drug exposure, a long half-life, and the convenience of a small pill, has the opportunity to improve patient outcomes for the treatment of obesity.”
Ascletis Pharma Inc. is a fully integrated biotechnology company focused on the development and commercialization of potential best-in-class and first-in-class therapeutics to treat metabolic diseases. Utilizing its proprietary Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) and Ultra-Long-Acting Platform (ULAP) technologies as well as Peptide Oral Transport ENhancement Technology (POTENT), Ascletis has developed multiple drug candidates in-house, including both small molecules and peptides, such as its lead programme, ASC30, a small molecule GLP-1R agonist designed to be administered once daily orally and once monthly to once quarterly subcutaneously as a treatment therapy and a maintenance therapy for chronic weight management; ASC36, an amylin receptor peptide agonist, ASC35, a once-monthly subcutaneously administered GLP-1R/GIPR dual peptide agonist and ASC37, a GLP-1R/GIPR/GCGR triple peptide agonist, and ASC39, a potent and amylin-selective oral small molecule amylin receptor agonist, for chronic weight management.
|