Ascletis-B (01672.HK): Oral Small-molecule GLP-1 ASC30 Initiates Global Phase III Clinical Trials; First-in-class Triple-target FDC Achieves 15.2% Weight Loss in Preclinical Studies
NewTimeSpace News: Ascletis Pharma Inc. (01672.HK) announced that once-daily oral small-molecule GLP-1 ASC30 has obtained FDA clearance to initiate global Phase III clinical studies. Two pivotal trials will be conducted in the United States, Europe and Canada, enrolling approximately 4,600 obese or overweight subjects. Meanwhile, the Company disclosed first-in-class oral small-molecule GLP-1/GIP/amylin triple-target fixed-dose combination (FDC) achieved up to 15.2% weight loss in non-human primates, representing a relative improvement of 120% compared with the dual-target formulation.
NewTimeSpace News: Ascletis Pharma Inc. (01672.HK) issued a voluntary announcement on 3 August 2026. The Company’s once-daily oral small-molecule GLP-1 candidate ASC30 has secured FDA approval for Phase III development, launching the global Phase III programme consisting of AURORA-1 and AURORA-2. Around 4,600 obese or overweight subjects will be recruited across the United States, Europe and Canada with a 72-week treatment period. Topline results are expected in the third quarter of 2028. The Company plans to submit an NDA to the FDA by the end of 2028 and an MAA to the EMA in early 2029.
Separately, the Company unveiled preclinical findings for its first-in-class once-daily oral small-molecule GLP-1/GIP/amylin triple-target agonist fixed-dose combination (ASC30_48_39FDC). After seven days of administration in non-human primates, the candidate achieved up to 15.2% body weight reduction, marking a maximum relative improvement of 120% versus the GLP-1/amylin dual-target combination (ASC30_39FDC). The Company stated that it holds sufficient cash flow to cover the ASC30 filing and operational expenses through 2029.
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