Ascletis' oral GLP-1 ASC30 cut HbA1c 1.7% versus placebo in U.S. Phase II

what happened

Ascletis Pharma, listed in Hong Kong under 1672.HK, said its oral small-molecule GLP-1 receptor agonist ASC30 met its primary endpoint in a 13-week U.S. Phase II study of 100 adults with type 2 diabetes. According to the company's PRNewswire announcement, the drug lowered HbA1c relative to placebo by 1.7%, 1.6% and 1.7% at 12 weeks for the 40 mg, 60 mg and 80 mg doses, from an average baseline of 8.3%.

Placebo-adjusted weight loss reached 4.4%, 3.8% and 4.0% at 13 weeks, a secondary endpoint, and no plateau was observed. The company reported zero discontinuations due to gastrointestinal side effects, a single discontinuation for any adverse event, and no hepatic safety signal. Ascletis expects gastrointestinal tolerability to improve in its Phase III diabetes program, where titration will be slowed to once every four weeks.

Chairman and CEO Jinzi Jason Wu said the data "demonstrate that ASC30 has the potential to be a best-in-class oral small molecule GLP-1 for diabetes."

why it matters

For a single small-cap biotech, the readout matters mainly to Ascletis shareholders and to investors tracking the race for oral treatments of obesity and diabetes. The company is also running a global Phase III obesity program with two pivotal trials, enrolling about 4,600 participants, with topline data expected in the third quarter of 2028.

tags

instruments