Dipexium Pharmaceuticals, Inc., a late-stage pharmaceutical company focused on the development and commercialisation of Locilex (pexiganan cream 0.8%), a novel, broad-spectrum, topical antibiotic peptide, announced that it has completed the patient enrollment objective in the OneStep-2 pivotal phase 3 clinical trial in accordance with the requirements set forth in the OneStep-2 clinical trial protocol.
The company also announced that the OneStep-1 pivotal phase 3 clinical trial has passed the 98% enrollment mark and is expected to reach the 180 patient enrollment objective imminently. OneStep-1 and OneStep-2 are identical, pivotal phase 3 clinical trials conducted under a Special Protocol Assessment (SPA) agreement between the US Food and Drug Administration (FDA) and Dipexium 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 (PK) analysis as set forth in the OneStep clinical trial protocols.
The company anticipates announcing top-line data from the pivotal phase 3 clinical trials in the third quarter of 2016 and is targeting a New Drug Application (NDA) submission with the FDA and a Marketing Authorization Application (MAA) submission with the European Medicines Agency in the first half of 2017.
"We are very pleased to announce the completion of enrollment in the OneStep-2 trial and the significant progress made with enrollment in the OneStep-1 trial. We look forward to reporting top-line data from these pivotal phase 3 clinical trials in the third quarter. If successful, Locilex, has the potential to be the first product specifically approved in the US for the treatment of patients with Mild DFI," said David P. Luci, president and chief executive officer of Dipexium.
OneStep-1 and OneStep-2 are identical, double-blind, placebo-controlled clinical trials conducted simultaneously. The primary objective is to establish the clinical superiority and safety of topical Locilex plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of Mild DFI. Patients are randomized 1:1 to receive either topical Locilex plus standard local wound care or placebo cream plus standard local wound care for 14 days, with final evaluation at day 28.
The primary endpoint of the trials is clinical response, which is defined as infection resolved per the judgment of each treating physician using the 2012 Infectious Disease Society of America (IDSA) Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections. Secondary endpoints include microbiological success, which is defined as complete microbiological response, as well as the incidence and severity of adverse events.