Ascletis Pharma Inc. (Ascletis) (HKEX: 1672), a fully integrated biotechnology company, announced on Sunday that it has dosed its first participant in a global Phase III clinical programme of ASC30 for chronic weight management.
ASC30 is an investigational, proprietary once-daily oral small molecule glucagon-like peptide-1 receptor (GLP-1R) agonist that is developed for chronic weight management and diabetes.
The global Phase III clinical programme includes two pivotal, multicentre, randomised, double-blind, placebo-controlled Phase III trials - AURORA-1 (NCT07743463) and AURORA-2 (NCT07743450) - assessing the long-term efficacy, safety, and tolerability of ASC30 once-daily oral tablets in around 4,600 participants across the US, Europe, and Canada.
Ascletis plans to reveal top-line data from the programme in the third quarter of 2028. It is expected to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) by the end of 2028 and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in early 2029.
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