This Phase III clinical trial is a randomized, double-blind, placebo-controlled, multicenter clinical trial in
The co-primary efficacy endpoints are: proportion of subjects achieving treatment success at week 12, percentage change from baseline in total lesion count, and percentage change from baseline in inflammatory lesion count (ILC) at week 12. Treatment success is defined as at least a 2-point reduction in Investigator's Global Assessment (IGA) score from baseline and a score of clear (0) or almost clear (1).
The protocol of Phase III clinical trial has been agreed by
On
ASC40 is an oral, selective small molecule inhibitor of FASN. Mechanisms of ASC40 for treatment of acne are (1) direct inhibition of facial sebum production, through inhibition of de novo lipogenesis (DNL) in human sebocytes and (2) inhibition of inflammation, through decreasing cytokine secretion and Th17 differentiation.
Acne is the eighth most prevalent disease in the world and affects more than 640 million people globally [1]. Adherence to topical therapies is worse when compared with that for oral agents: an estimated 30% to 40% of patients do not adhere to their topical treatments [2]. Currently, effective oral treatment for acne are mainly isotretinoin which can cause a lot of severe adverse events such as hepatotoxicy, hearing impairment and depression, etc. ASC40 has the potential to be a first-in-class, once-daily oral acne therapeutic with high patient compliance.
'There has been a lack of new drugs on the market for acne treatment. ASC40 is an oral drug candidate with a novel mechanism of action for acne treatment.' Professor Leihong Xiang, Chief Physician of
'I'm glad that Ascleits has achieved another milestone, which reflects our strong execution to advance our pipeline programs into late-stage clinical development. As a first-in-class drug candidate with novel mechanism for acne treatment, ASC40 has demonstrated significant efficacy and good safety in the Phase II study. We believe that the novel mechanism of action will translate ASC40 into a safe and effective treatment for moderate to severe acne treatment.' said Dr.
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