Dipexium Receives European Medicines Agency Designation as a Small & Medium Enterprise

Dipexium Pharmaceuticals, Inc. recently announced it has been granted Small and Medium Enterprise (SME) designation by the European Medicines Agency (EMA). The company recently completed its pivotal Phase III clinical trials (OneStep-1 and OneStep-2) with Locilex in mild infections of diabetic foot ulcers in the US under a Special Protocol Assessment (SPA) agreement from FDA. Dipexium expects to have top-line data from these trials available for release shortly as its scientific advisory team is finalizing the database, which currently remains blinded.

The SME designation was established by EMA to promote innovation and the development of new medicinal products by smaller companies. Companies with SME status are eligible to receive financial incentives as well as administrative and regulatory support through national and regional level programs. These benefits include access to dedicated EMA personnel during the clinical development process as well as reductions in fees associated with regulatory procedures, such as Scientific Advice, Marketing Authorizations, and inspections.

“We are pleased to have SME designation, which allows us to benefit from financial incentives and support from the EMA as we aim to bring Locilex to the global pharmaceutical marketplace,” said David P. Luci, President and Chief Executive Officer of Dipexium. “With prior guidance from the EMA, the results from our clinical trials conducted in the US will form the basis for the planned Marketing Authorization Application to be submitted shortly after filing our New Drug Application Amendment with the FDA.”

Dipexium Pharmaceuticals, Inc. is a late-stage pharmaceutical company focused on the development and commercialization of Locilex (pexiganan cream 0.8%), a novel, broad spectrum, topical antimicrobial peptide. Initially, Locilex is targeted for the treatment of mild infections of diabetic foot ulcers. Based on a compilation of available clinical and microbiology data, Locilex is also considered a promising product candidate to treat other mild and moderate skin and skin structure infections, including infected decubitus ulcers, infected burns, infected surgical wounds, infected animal bites, and nasal colonization of methicillin-resistant staphylococcus aureus (MRSA). For more information, visit www.dipexiumpharmaceuticals.com.

OneStep-1 and OneStep-2 were identical, double-blind, placebo-controlled clinical trials conducted simultaneously that enrolled a total of 389 patients at 59 separate centers in the US. The primary objective was 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 were 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. Other clinical endpoints include several measurements with respect to the timing to, and the extent of, wound healing. The FDA has agreed to a Special Protocol Assessment (SPA) with Dipexium for Locilex’s pivotal Phase III clinical trial program in Mild DFI.