Ascletis' ASC30 shows superior drug exposure and weight loss in Phase Ib

Ascletis Pharma Inc. announced favorable topline pharmacokinetic (PK) data from its U.S. Phase Ib multiple ascending dose (MAD) study of ASC30, an oral once-daily tablet for obesity. The study, involving participants with a BMI of 30-40 kg/m², showed that at steady state, ASC30 demonstrated drug exposures (AUC0-24h) of 3,560 ng·h/mL for the 20 mg cohort and 5,060 ng·h/mL for the 40 mg cohort. These exposures were associated with placebo-adjusted mean body weight reductions from baseline of 4.5% (20 mg) and 6.5% (40 mg) after 28 days.

A cross-trial comparison revealed that 20 mg and 40 mg ASC30 exhibited approximately 2.3-fold and 3.3-fold greater drug exposure, respectively, than 24 mg orforglipron oral once-daily capsule (AUC0-24h 1,520 ng·h/mL), which achieved only a 3.6% placebo-adjusted mean body weight reduction. Notably, ASC30 showed no incidences of vomiting in the 20 mg cohort, in contrast to orforglipron's 18% vomiting rate at 24 mg. The study reported ASC30 to be safe and well-tolerated, with no serious adverse events or Grade 3 or higher adverse events, including GI-related issues.

The company has completed enrollment for its U.S. Phase IIa study of ASC30, involving 125 participants with obesity or overweight, with topline data anticipated in the fourth quarter of 2025. ASC30 is an investigational GLP-1R biased small molecule agonist with U.S. and global compound patent protection until 2044.