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

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 United States. 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 3 clinical trial program in Mild DFI.

Forward-Looking Statements

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Company Contacts:

Lisa Wilson
Investor Relations
In-Site Communications, Inc.
212-452-2793
lwilson@insitecony.com

David Garrett
Vice President, Finance & Corporate Development
Dipexium Pharmaceuticals, Inc.
212-269-2834
info@dipexium.com

© 2016 Dipexium Pharmaceuticals, Inc.  All rights reserved.

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SOURCE Dipexium Pharmaceuticals, Inc.