Dipexium Pharmaceuticals’ (NASDAQ:DPRX) OneStep-1 and OneStep-2 pivotal Phase 3 clinical trials have reached the 75% enrollment milestone in total, with each study having enrolled nearly the same number of patients.
OneStep-1 and OneStep-2 are identical Phase 3 trials, with 180 patients per clinical trial. They are being conducted under a SPA with the FDA for evaluation of Locilex for the treatment of patients with mild infections of diabetic foot ulcers.
The company anticipates completing the trials in the second half of 2016 and is targeting a NDA submission with the FDA in the first half of 2017 and a MAA submission with the European Medicines Agency in the second half of 2017.
