Ascletis Pharma has commenced the Phase III clinical trial of its drug candidate, ASC40 (Denifanstat), to treat patients with moderate to severe acne vulgaris in China.

The multicentre, double-blind, randomised, placebo controlled trial will assess the efficacy and safety of ASC40. 

It will enrol 480 participants who will be randomised into a 1:1 ratio to receive either 50mg of the drug or a placebo orally once a day for a total of 12 weeks.

The proportion of participants attaining treatment success at week 12 and percentage variation in total lesion count and inflammatory lesion count (ILC) from baseline are the trial’s co-primary efficacy endpoints. 

A minimum of a two-point decline in the Global Assessment (IGA) score, as assessed by an investigator from baseline, and a score of clear (0) or almost clear (1) will be considered as treatment success.

The trial protocol received approval from the China National Medical Products Administration’s Center for Drug Evaluation, as well as from the Institutional Review Board of Huashan Hospital, Fudan University.

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By GlobalData

An oral, small molecule inhibitor of fatty acid synthase (FASN), ASC40 was licenced by Ascletis from Sagimet Biosciences. 

Ascletis currently has the rights for the development, manufacturing, and commercialisation of the drug candidate in Greater China. 

The company reported that a Phase II trial of ASC40 to treat acne vulgaris met the primary and key secondary goals in May 2023. It was also demonstrated to have good safety and efficacy.

Ascletis founder, chairman and CEO Dr Jinzi Wu said: “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.”

In September, the company reported positive interim data from an expansion cohort of the Phase IIb trial of ASC22 (Envafolimab) to treat chronic hepatitis B.