HbA1c primary endpoint
Ascletis Pharma said ASC30, its once-daily oral small molecule GLP-1 receptor agonist, met the primary endpoint of a U.S. Phase II study in 100 participants with type 2 diabetes. Placebo-adjusted HbA1c reductions from baseline at 12 weeks were 1.7% for 40 mg (n=20), 1.6% for 60 mg (n=29) and 1.7% for 80 mg (n=28), the company said, with the difference from placebo statistically significant at p < 0.0001. Participants had an average HbA1c of 8.3% at baseline.
Weight loss at 13 weeks
On the secondary endpoint, placebo-adjusted body weight reduction from baseline at 13 weeks was 4.4%, 3.8% and 4.0% for the 40 mg, 60 mg and 80 mg groups respectively, and no plateau was observed, the company said. Participants had an average body weight of 93.7 kg at baseline.
Safety and tolerability
ASC30 titrated weekly to maintenance doses showed favourable safety and gastrointestinal tolerability, with no study discontinuations due to GI adverse events, Ascletis said. There was one discontinuation due to any adverse event, in the 80 mg group (1/80, 1.3%, hiccup); the placebo group had none. All drug-related adverse events were grade 1 or grade 2 in severity and there were no drug-related serious adverse events, the company said.
No hepatic safety signal was observed, and there were no elevations of alanine transaminase, aspartate aminotransferase or total bilirubin during the treatment period.
Phase III obesity programme
Type 2 diabetes is the second indication in development for ASC30, in addition to obesity. The company said its global Phase III programme in obesity has two pivotal trials, AURORA-1 and AURORA-2, enrolling approximately 4,600 participants with obesity or overweight in the U.S., Europe and Canada. Topline data from that programme are expected in the third quarter of 2028, with a U.S. Food and Drug Administration new drug application for obesity expected by the end of 2028 and a European Medicines Agency marketing authorisation application expected in early 2029.