Ascletis Unveils Robust Pre-Clinical Data for Industry-Leading Once-Weekly Oral Peptide Portfolio Targeting Obesity

Bulletin Express10-20 08:20

Ascletis Pharma Inc. (Ascletis) has released encouraging pre-clinical results for what it calls the industry’s most comprehensive once-weekly oral peptide pipeline for obesity and related metabolic disorders.

The programme centres on ASC36o, a first-in-class, once-weekly oral amylin-receptor agonist already in a Phase I study in the United States. In non-human primates (NHPs), ASC36o tablets generated a half-life of up to 167 hours (≈7 days) and oral bioavailability of 6%–8%. In a diet-induced obesity rat model, ASC36 lowered body weight 32% more than eloralintide and 91% more than petrelintide. Top-line human pharmacokinetic data are targeted for release by end-2026.

Building on ASC36o, Ascletis is developing two first-in-class, once-weekly oral fixed-dose combination (FDC) peptides: • ASC36_37o FDC (amylin/GLP-1/GIP/GCG) • ASC36_35o FDC (amylin/GLP-1/GIP)

In NHP studies, these FDCs extended pharmacokinetic profiles beyond monotherapy. ASC36’s half-life lengthened from roughly 7 days to about 8.8 days in ASC36_35o and 8.3 days in ASC36_37o, while its oral bioavailability rose to at least 10% in both combinations. FDA Investigational New Drug (IND) submissions for the two FDCs, as well as for single-agent ASC37o (GLP-1/GIP/GCG) and ASC35o (GLP-1/GIP), are planned for 4Q 2026.

All five candidates harness Ascletis’ proprietary Peptide Oral Transport ENhancement Technology (POTENT), which boosts absorption in both gastric and intestinal sites and reduces pharmacokinetic variability. Across the pipeline, steady-state oral bioavailability reaches up to >10%, with half-lives extending to approximately 8.8 days in NHPs—parameters viewed as sufficient for once-weekly oral dosing.

Chairman and CEO Dr. Jinzi Jason Wu highlighted the initiation of the U.S. Phase I trial for ASC36o as “another milestone,” underscoring Ascletis’ competitive positioning across the four validated peptide targets—amylin, GLP-1, GIP and GCG receptors.

Ascletis cautions that successful development, manufacture, and commercialization of ASC36o, its FDCs, ASC37o and ASC35o are not guaranteed.

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