Dipexium completes enrollment in one Locilex Phase 3 trial
Dipexium Pharmaceuticals (NASDAQ:DPRX) has completed the patient enrollment objective in the OneStep-2 Phase 3 clinical trial of its Locilex topical antibiotic peptide.
The company’s OneStep-1 Phase 3 clinical trial has passed the 98% enrollment mark and is expected to reach the 180-patient enrollment objective soon.
OneStep-1 and OneStep-2 are identical, Phase 3 clinical trials conducted under a Special Protocol Assessment agreement with the FDA for evaluation of Locilex for the treatment of patients with mild infections of diabetic foot ulcers (mild DFI).
Across both clinical trials, clinical trial sites are now in the process of being closed, with certain trial centers continuing enrollment for approximately 30 days to collect the required number of blood samples for pharmacokinetic analysis as set forth in the OneStep clinical trial protocols.
Dipexium anticipates announcing top-line data from the Phase 3 trials in the third quarter this year and is targeting a NDA submission with the FDA and a Marketing Authorization Application submission with the European Medicines Agency in the first half of 2017.
“If successful, Locilex, has the potential to be the first product specifically approved in the U.S. for the treatment of patients with mild DFI,” David Luci, president and CEO, said in a statement.