Ascletis Pharma has reported positive topline outcomes from its US Phase Ia single ascending dose (SAD) study of the oral tablet, ASC30, in obese individuals.
The study, which involved 40 obese subjects under fasting conditions, included five cohorts with various doses of the tablet.
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Up to 60 hours of long half-life and dose-proportional pharmacokinetics (PK) were demonstrated by the tablet, suggesting the feasibility of one time-a-day or less frequent dosing.
A cross-trial comparison revealed that a 5mg single dose of the tablet had 2.2 times the drug exposure of a 6mg dose of orforglipron, another small molecule oral glucagon-like peptide 1 (GLP-1) receptor agonist.
In cohort 5, the tablet’s highest dose (40mg) was administered to subjects under both fasting and fed conditions. The findings showed that the PK properties, including drug exposure and half-life, were consistent regardless of food intake.
The safety and tolerability of the tablet were confirmed in the Phase Ia SAD study, with gastrointestinal-related safety profiles comparable to or better than other GLP-1R agonists in development.
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By GlobalDataLiver enzyme levels, including ALT and AST, remained within normal ranges.
Ascletis Pharma founder, chairman and CEO Dr Jinzi Jason Wu said: “We are excited that the results from our Phase Ia SAD trial of ASC30 oral tablet, once daily in patients with obesity demonstrated potential best-in-class characteristics.
“As one small molecule, ASC30 potentially offers both once-daily oral and once-monthly subcutaneous injection dosing options.”
Developed using the company’s technology, the oral tablet formulation of ASC30 is stable at room temperature and showed 99% relative oral bioavailability in animal models.
The Phase Ib multiple ascending dose (MAD) study is progressing, with outcomes anticipated by the end of March this year.
In September 2023, the company enrolled all 120 subjects in its Phase III trial of ASC40 in conjunction with bevacizumab to treat recurrent glioblastoma (rGBM).
