Ascletis Pharma has dosed the first subject in Phase II clinical trial of oral therapy, ASC40, to treat moderate to severe acne.
ASC40 is a fatty acid synthase (FASN) selective inhibitor. A crucial enzyme, FASN controls de novo lipogenesis.
Sebum production in humans needs de novo lipogenesis, which is increased in acne and hindered by the FASN inhibitor ASC40.
The placebo-controlled, randomised, double-blind, multicentre trial in China will assess the safety and efficacy of ASC40 to treat individuals with moderate to severe acne.
It will enrol nearly 180 subjects who will be randomised into a 1:1:1:1 ratio with three active treatment groups or one placebo control arm to receive a once-daily oral dose of 25mg, 50mg or 75mg of ASC40 or placebo for 12 weeks.
The percentage change of total lesion count at week 12 compared to baseline and ratio of subjects, whose Investigator’s Global Assessment (IGA) grades are lowered by ≥2 grades at week 12 against baseline are the primary goals of the trial.
According to prior trials, ASC40 was found to be safe and hindered the production of human facial sebum in a dose-dependent manner.
Ascletis Pharma founder, chairman and CEO Dr Jinzi Wu said: “We have observed that ASC40 inhibited human facial sebum production in the Phase I clinical study.
“Based on the underlying mechanism of action of ASC40, I am looking forward to the data from this phase II study for the treatment of acne.”
The eighth most common ailment in the world, acne affects more than 640 million individuals globally.
In January 2019, Ascletis Pharma entered an exclusive licensing agreement with Suzhou Alphamab for the development of an investigational candidate, KN035, to treat viral diseases such as hepatitis B in Greater China.