ASCLETIS-B (01672.HK): First subject dosed in global Phase III program of oral GLP-1 agonist ASC30 for long-term weight management, targeting ~4,600 subjects

NewTimeSpace News: On 30 August 2026, Ascletis Pharma Inc. (stock code: 01672) voluntarily announced that the first subject has been dosed in the global Phase III clinical program of ASC30, a once-daily oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonist for long-term weight management. The program comprises two pivotal multicenter, randomized, double-blind, placebo-controlled Phase III trials, AURORA-1 (NCT07743463) and AURORA-2 (NCT07743450), evaluating the long-term efficacy, safety and tolerability of ASC30 in approximately 4,600 obese or overweight subjects in the United States, Europe and Canada.

According to the announcement, both trials have a 72-week treatment period and evaluate three maintenance doses (20 mg, 40 mg and 60 mg): AURORA-1 evaluates efficacy and safety in obese subjects (BMI ≥ 30 kg/m²) or overweight subjects (BMI ≥ 27 kg/m² with at least one weight-related comorbidity) without type 2 diabetes, while AURORA-2 evaluates efficacy and safety in obese or overweight subjects (BMI ≥ 27 kg/m²) with type 2 diabetes; the primary endpoint of both trials is the percent change in body weight from baseline at week 72.

Ascletis expects to report topline data for the AURORA Phase III program in the third quarter of 2028, and expects to submit a New Drug Application (NDA) to the US FDA by the end of 2028 and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in early 2029. If approved, ASC30 has the potential to become the second oral small-molecule GLP-1 receptor agonist launched in the United States and Europe. The Company maintains a robust balance sheet and sufficient cash on hand to cover the planned regulatory submissions in the US and Europe and support operations through 2029.

In terms of pipeline, in addition to the AURORA global Phase III monotherapy program, Ascletis is also developing the first oral small-molecule GLP-1/GIP dual-target agonist fixed-dose combination similar to tirzepatide (ASC30_48FDC), the first oral small-molecule GLP-1/GIP/amylin triple-target agonist fixed-dose combination similar to tirzepatide/eloralintide (ASC30_48_39FDC), and a fixed-dose combination of oral small-molecule GLP-1 and oral amylin (ASC30_39FDC). The announcement contains a warning statement under Rule 18A.05 of the Listing Rules.

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