US-based Dipexium Pharmaceuticals has started patient enrolment in the second of two pivotal Phase III clinical trials for its new drug aimed at treating diabetic patients with foot ulcers.
Under the two trials, OneStep-1 and OneStep-2, the new, broad-spectrum, topical antibiotic peptide, Locilex (pexiganan cream 0.8%), will be assessed for treating patients with mild infections of diabetic foot ulcers (DFI).
Approximately 47% of all patients with diabetic foot infections first present at the mild stage, according to medical literature.
At present, there are no antibiotics or specific systemic / topical medication with US Food and Drug Administration (FDA) approval to treat patients with mild DFI.
The FDA has agreed to a special protocol assessment (SPA) with Dipexium for Locilex’s pivotal Phase III clinical trial programme.
Dipexium president and chief executive officer David Luci said: “We are delighted to have OneStep-1 and OneStep-2 actively enrolling patients simultaneously and we expect to continue the momentum throughout H2 2014.”
Dipexium executive chairman Robert DeLuccia said: “We look forward to completing the clinical and regulatory pathway for Locilex and proceeding with the submission of our new drug application (NDA) in H2 2015 as planned.”
Both OneStep-1 and OneStep-2 are identical, double-blind, placebo-controlled clinical trials being carried out simultaneously. Each trial will enrol around 180 patients at 20 separate centres in the US.
During the trials, patients will be randomised 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, defined as infection resolved per the judgment of each treating physician using the 2012 Infectious Disease Society of America’s clinical practice guideline for the diagnosis and treatment of diabetic foot infections.
The trials’ secondary endpoints include microbiological success, which is defined as complete microbiological response, and the incidence and severity of adverse events.