Ascletis Pharma Begins U.S. Phase I Trial for Once-Weekly Oral Peptide Drug ASC36o
Ascletis Pharma, Inc. (HKEX:1672) has started a Phase I clinical study in the United States for ASC36o, an oral peptide candidate targeting obesity. The clinical trial follows positive preclinical findings showing that candidates in the company's once-weekly oral peptide pipeline demonstrated extended half-lives of approximately 7 to 8.8 days and oral bioavailability of at least 6% in non-human primates.
High oral bioavailability and extended half-lives are essential for delivering peptide drugs in convenient once-weekly oral doses. In preclinical testing on non-human primates, ASC36o achieved an oral bioavailability of 6% to 8%, which increased to 10% or higher when formulated in fixed-dose combinations. Additionally, ASC36o generated stronger weight loss results in diet-induced obese rats compared to rival treatment candidates eloralintide and petrelintide.
Investors will look for initial human results to confirm whether the strong preclinical performance translates into people. Ascletis Pharma expects to report topline pharmacokinetic data from the U.S. Phase I trial of ASC36o by the end of 2026. Shares of Ascletis Pharma rose 1.12% to 5.85 HKD following the update.
Key points
- Ascletis Pharma, Inc. (HKEX:1672) launched a U.S. Phase I clinical study for its oral peptide drug candidate ASC36o.
- Preclinical testing in non-human primates showed half-lives of 7 to 8.8 days and oral bioavailability of 6% to 8%.
- Fixed-dose combination tablets boosted oral bioavailability in non-human primates to 10% or higher.
- ASC36o demonstrated greater weight loss in diet-induced obese rats than peer compounds eloralintide and petrelintide.
- Topline human pharmacokinetic data from the ASC36o Phase I trial is expected by the end of 2026.
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What preclinical data did Ascletis Pharma report for ASC36o?
Ascletis Pharma reported that ASC36o achieved half-lives of 7 to 8.8 days and oral bioavailability of 6% to 8% in non-human primates, rising to 10% or higher with fixed-dose combinations. It also outperformed peer candidates in weight loss tests in diet-induced obese rats.
When will human trial data for ASC36o be available?
Ascletis Pharma has initiated a U.S. Phase I study for ASC36o and expects to release topline pharmacokinetic data from the clinical trial by the end of 2026.
How is ASC36o administered?
ASC36o is an oral peptide designed for once-weekly dosing.