Dipexium Pharmaceuticals has initiated patient enrollment in the first of two pivotal phase III clinical trials, known as OneStep-1 and OneStep-2, evaluating Locilex (pexiganan cream 0.8%), the company's novel, broad-spectrum, topical antibiotic peptide, for the treatment of patients with mild infections of diabetic foot ulcers, or Mild DFI.
According to medical literature, approximately 47% of all patients with diabetic foot infections first present at the mild stage. Currently, there are no antibiotics, systemic or topical, which are FDA approved specifically 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 program in Mild DFI.
"Current therapy for Mild DFI is a choice between several systemic antibiotics prescribed 'off-label.' These products are associated with systemic side effects, including black box warnings, and are known to contribute to the proliferation of resistant bacteria," said David P. Luci, president and CEO of Dipexium.
Robert J. DeLuccia, executive chairman of Dipexium, said, "In a prior phase III clinical trial in Mild DFI, topical Locilex demonstrated non-inferiority to an oral fluoroquinolone antibiotic….In over 500 patients treated to date, Locilex has demonstrated an excellent safety and tolerability profile, no systemic absorption, and no bacterial resistance or cross-resistance to other antibiotics. We look forward to completing the OneStep trials, which we anticipate will occur in the first quarter of 2015."
OneStep-1 and OneStep-2 are identical, double-blind, placebo-controlled clinical trials conducted simultaneously that will each enroll approximately 180 patients at 20 separate centers in the U.S. 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 will be 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.