Key Findings
Ascletis Pharma has advanced its lead candidate, ASC36o, a once-weekly oral amylin receptor peptide agonist, into a Phase 1 study in the U.S. Preclinical data in non-human primates (NHPs) shows ASC36o has a half-life of up to 167 hours (approximately 7 days) and oral bioavailability between 6% and 8%. In diet-induced obesity (DIO) rat studies, ASC36o demonstrated body weight reduction 32% and 91% greater than eloralintide and petrelintide, respectively.
Technical Details
The company’s pipeline leverages Peptide Oral Transport ENhancement Technology (POTENT), which increases oral bioavailability via both gastric and intestinal absorption while reducing within-subject and between-subject variability. This technology supports several configurations:
- ASC36o: Amylin receptor peptide agonist.
- ASC36_35o FDC: A fixed-dose combination (FDC) of amylin receptor, GLP-1R, and GIPR agonists. In NHPs, this combination increased the half-life of ASC36o to approximately 8.8 days (up to 212 hours) and bioavailability to ≥10%.
- ASC36_37o FDC: A quadruple peptide agonist (amylin receptor, GLP-1R, GIPR, and GCGR). In NHPs, this combination showed a half-life of approximately 8.3 days (up to 200 hours) and bioavailability of ≥10%.
- ASC35o and ASC37o: Once-weekly oral dual (GLP-1/GIP) and triple (GLP-1/GIP/GCG) peptide agonists, respectively.
Background and Context
The pipeline is designed to cover all four validated targets for obesity and metabolic diseases: amylin, GLP-1, GIP, and GCG receptors. By combining these targets into single-pill FDCs, Ascletis intends to expand the population treatable with oral agents compared to single-agent therapies.
Significance and Outlook
The combination of high oral bioavailability and extended half-lives is intended to make once-weekly oral dosing commercially viable. Ascletis expects to receive topline human pharmacokinetic data for ASC36o by the end of 2026. Additionally, the company expects to submit Investigational New Drug (IND) applications to the FDA for its four other once-weekly oral peptide programs in the fourth quarter of 2026.
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