Ascletis says oral acne drug shows "exceptional efficacy"
Hong Kong biotech Ascletis is planning to file a new oral treatment for acne for approval in China soon, on the back of new phase 3 data that suggests it could be a big step forward in treatment for the skin disorder.
Denifanstat (ASC40) – vying to become the first in a new class of fatty acid synthase (FASN) inhibitors for acne – was significantly better than placebo at clearing skin in patients with moderate-to-severe acne over 12 weeks of follow-up in the study, which involved 484 Chinese subjects.
At the end of that period, the treatment success rate was 33.2% with a once-daily 50mg dose of denifanstat versus 14.6% for a matched placebo, with the number of inflamed lesions reduced by 63.5% and 43.2%, respectively.
Ascletis' drug also reduced the number of non-inflammatory lesions by 51.9%, compared to a 28.9% fall in the control group, which is an important finding as it backs up the drug's proposed mechanism of action in reducing inflammation and sebum production, as well as potentially inhibiting fibrosis, a process central to scarring.
Ascletis licenses denifanstat from US biotech Sagimet, which has taken the drug into mid-stage clinical testing for metabolic dysfunction-associated steatohepatitis (MASH) and has a follow-up FASN inhibitor (TVB-3567) in phase 1 testing as a potential acne treatment in the US and other world markets.
Acne affects around 640 million people worldwide, but current treatment options are plagued by limited efficacy, side effects like skin irritation and liver toxicity, and – in the case of antibiotic therapies – the risk of encouraging antimicrobial resistance (AMR).
Ascletis said it has data indicating denifanstat is 98% more effective at treating acne than sarecycline, and 178% better than doxycycline, both antibiotics, and 60% better than clascoterone cream, which is sold in the US as Winlevi by Sun Pharma and was approved in 2020.
Armed with the new data, Ascletis is planning to file for approval with China's National Medical Products Administration (NMPA) shortly, saying it offers "both exceptional efficacy and patient compliance with a favourable safety and tolerability profile."
The Chinese results have also been welcomed by Dr. Neal Bhatia, a past vice president of the American Academy of Dermatology (AAD), who said it is "very exciting to see this novel oral acne product candidate progressing through development in light of the limited innovation within the acne space over the past 40 years."
