Sagimet Biosciences has announced positive results from the trial of its license partner Ascletis Pharma’s denifanstat in moderate to severe acne.
The phase 3 ASC40-304 trial evaluated the safety profile of denifanstat in patients with moderate to severe acne. These patients had previously been enrolled in the phase 3 ASC40-303 trial. ASC40-304 found that denifanstat was generally well tolerated by patients, with only two types of treatment-emergent adverse events (TEAEs) having an incidence rate higher than 5% and all adverse events being mild or moderate.
The trial also found that patients receiving denifanstat demonstrated improvements in all secondary endpoints, beyond those improvements noted at 12 weeks of study. These endpoints included the number of subjects whose Investigator’s Global Assessment (IGA) score decreased by at least two points and the percentage reduction in total skin lesion count.
Full results from the study will be presented in future publications and medical meetings.
More than 50 million people across the US live with acne, and 5.1 million are annually treated by dermatologists for the condition. It has no cure, and controlling it often requires chronic treatment. Topical therapies have shown lower adherence than oral therapies. Around 30-40% of patients do not adhere to topical treatment, highlighting an unmet medical need for oral therapies such as denifanstat, which is delivered in pill form.
Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor. It is currently being developed by Ascletis as ASC40 for acne treatment in China, and by Sagimet for metabolic dysfunction-associated steatohepatitis (MASH) outside of China.
David Happel, CEO of Sagimet, said: “The topline results from Ascletis’ phase 3 open-label acne trial in China build additional confidence in the clinical potential of FASN inhibition in acne. These results demonstrate FASN inhibition’s potential as a novel mechanism of action for the treatment of acne.”
Dr Neal Bhatia, director of clinical dermatology at Therapeutics Clinical Research in San Diego and former vice president of the American Academy of Dermatology, added: “For moderate to severe acne patients, who are currently underserved by older agents, the potential of a new therapeutic option would be a welcome addition to the current treatment armamentarium.”