The randomized, multicenter, vehicle-controlled Phase 3 study will include approximately 350 patients in North America. The patients will be evaluated over 52 weeks and the primary endpoint will be the proportion of subjects achieving complete cure of their target nail. The company expects to start enrolling patients in the second quarter of this year. The study design builds on the experience gained from the previous Phase 3 studies. Moberg Pharma will cooperate with the same CRO, lead investigator and successful sites from the previous North American study. The purpose of the new study is to facilitate market approval in the US as well as strengthen the product's clinical evidence and marketing claims globally.

"For market approval in the U.S., the FDA typically requires two studies that demonstrate statistical superiority of the active drug versus its vehicle (placebo) for the primary endpoint. The first study was successfully completed in 2019 and we are now conducting the second study. The North American study is a top priority in the near future, in addition to the registration process in Europe where our goal is to receive first market approval and launch in 2023", says Anna Ljung, CEO of Moberg Pharma AB.