Aslan Pharmaceuticals to advance farudodstat into Phase 2 clinical testing

ASLAN Pharmaceuticals announced that it is advancing its clinical program to investigate farudodstat, an oral dihydroorotate dehydrogenase, DHODH, inhibitor, in a Phase 2 proof-of-concept trial as a potential first-in-class treatment for alopecia areata, AA. "We are excited to advance the clinical development of farudodstat, which has the potential to be a first-in-class therapy addressing the unmet needs of alopecia areata patients," commented Dr Carl Firth, Chief Executive Officer, ASLAN Pharmaceuticals. "Despite recent advancements in treatment options, the long-term safety of therapies for AA remains a top priority for physicians. We have generated encouraging data that supports our belief that farudodstat can prevent, and potentially restore, the loss of immune privilege in hair follicles, offering a safe and effective treatment option for AA with a competitive profile." The Phase 2a proof-of-concept trial is a 2:1 randomized trial, with patients receiving oral doses of either farudodstat or placebo twice daily for 12 weeks, followed by a crossover treatment period. The trial will recruit about 60 patients in the US and enrollment is expected to begin in the second quarter of 2023. The interim topline readout following the first 12-week treatment period is expected in 1Q 2024 and will inform the design of the subsequent Phase 2b dose-ranging study. The primary objective of the trial is to evaluate the safety, tolerability and efficacy of farudodstat in adult subjects with severe alopecia areata.