Cully Pharmaceutical-B (01672) issued an announcement. The board of directors announced the 2024 US Skin to be held in San Diego, USA...
Zhitong Finance App News, Collie Pharmaceutical-B (01672) issued an announcement. The board of directors announced the final results of the Phase II study on the treatment of acne with ASC40, a first-of-its-kind fatty acid synthase (FASN) inhibitor, in the form of a poster at the 2024 American Academy of Dermatology (AAD) annual meeting held in San Diego, USA.
This phase II trial (NCT05104125) is a randomized, double-blind, placebo-controlled, multicenter study. 180 patients were given 25 mg\ 50 mg\ 75 mg ASC40 or placebo in a 1:1:1:1 ratio, once daily, treated for 12 weeks and followed up for 2 weeks. The efficacy and safety of ASC40 compared to placebo have been evaluated.
Results showed that at weeks 2, 4, 8, and 12, total skin damage, inflammatory and non-inflammatory skin injury counts, treatment success, and overall investigator assessment (IGA) decreased by ≥2 compared to baseline, and the percentage and absolute change in total skin damage was assessed. The above efficacy indicators generally improved from week 2 to week 12 at all doses. 50 mg once a day showed the best efficacy: 14.3% and 16.2% of patients treated successfully after placebo correction and reduced IGA of 2 or more, respectively. The median percentage (absolute) changes in total skin lesion and inflammatory skin damage counts compared to baseline after placebo correction were -27.1% (-23.5) and -33.5% (-13) (p = 0.008 (0.030) and 0.003 (0.003)), respectively.
Conclusion: According to the efficacy and safety data of this phase 2 trial, a phase 3 clinical trial of 50 mg ASC40 once a day for 12 weeks has been initiated.
Clarion has obtained exclusive rights in the development, production and commercialization of ASC40 in Greater China from Sagimet Biosciences Inc.