Dipexium Granted Special Protocol Assessment by the FDA for Phase 3 Registration Trial in Mildly Infected Diabetic Foot Ulcers With Locilex™

NEW YORK, Jan. 3, 2013 /PRNewswire/ -- Dipexium Pharmaceuticals, LLC today announced that it has reached an agreement with the U.S. Food and Drug Administration ("FDA") on a Special Protocol Assessment ("SPA") for an upcoming Phase 3 registration trial in mild infections of diabetic foot ulcers with Locilex™ (pexiganan acetate cream 1%), an antibiotic peptide formulated as a topical cream.  The SPA agreement states that the proposed trial protocol design, clinical endpoints and planned analyses are acceptable to the FDA to support a regulatory submission.

"We are pleased with the agreement with the FDA which provides us with a clearly defined development and regulatory pathway for marketing approval of Locilex™ in mild infections of diabetic foot ulcers," stated Robert J. DeLuccia co-Managing Partner of Dipexium.  "We believe pivotal Study DPX-305 will provide clinical justification to establish Locilex™ as the standard of care for the treatment of patients with mildly infected diabetic foot ulcers, a growing worldwide market currently estimated at approximately $1.5 billion," stated David P. Luci, co-Managing Partner of Dipexium. 

Study Design

Study DPX-305 will be a randomized, double-blind, multi-center, superiority, placebo-controlled Phase 3 Study of Pexiganan Cream 1% (Locilex™) applied twice daily for 14 days to treat adult patients with mild infections of diabetic foot ulcers in the United States.   Study DPX-305 will involve approximately 180 patients and the primary efficacy endpoint is resolution of infection in the medical judgment of each treating physician in accordance with the standardized guidance set forth in the 2012 Infectious Disease Society of America Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections (the "DFI Treatment Guidelines").  The DFI Treatment Guidelines were published in the June 15, 2012 edition of Clinical Infectious Disease and is available on our website at www.dipexiumpharmaceuticals.com.      

About Special Protocol Assessments

The SPA process is a procedure by which the FDA provides official evaluation and written guidance on the design and size of proposed protocols that are intended to form the basis for a Biologics License Application ("BLA") or New Drug Application ("NDA"). Final marketing approval depends on the results of efficacy, the adverse event profile and an evaluation of the benefit/risk of treatment demonstrated in the Phase 3 trial as well as, in our case, the results of Study DPX-306, an identical Phase 3 study intended to be conducted simultaneously with Study DPX-305.

About Locilex™

Locilex™ (pexiganan acetate cream 1%) is a broad spectrum, topical antimicrobial peptide which is chemically synthesized from the skin of the African clawed frog. Locilex™ has a novel, bactericidal mechanism of action uncommon among antibiotics currently marketed which generally inhibit pathogen growth. Locilex™ (positively charged) forms an alpha helix and disrupts the lipid bilayer of the bacterial cell wall (negatively charged) thereby creating an opening into which intracellular fluid, extracellular fluid and water enter, effectively lysing the bacterial cell.

Locilex™ has been used successfully in Phase 3 clinical studies demonstrating significant clinical benefit in patients with mild or moderate diabetic foot infections.  Dipexium has supported the Locilex™ clinical database recently by conducting microbiology studies that highlight the sensitivity of resistant bacteria to Locilex™, including methicillin-resistant Staphylococcus aureus (MRSA), vancomyn-resistant enterococcus (VRE), extended-spectrum β-lactamase (ESBL)  and multi-drug resistant (MDR) bacteria.  Because of the increased prevalence throughout the world of multi-drug-resistant bacteria and XDR bacteria in all types of bacterial skin infections, Locilex™ may provide an important therapeutic advance.

In microbiology studies conducted recently, Locilex™ 's active ingredient demonstrated a high level of activity against multi-drug resistant (MDR) bacteria, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococcus (VRE) and extended-spectrum β-lactamase (ESBL) and other resistant pathogens. Because of the increased prevalence throughout the world of multi-drug-resistant bacteria and XDR bacteria in all types of bacterial skin infections, Locilex™ may provide an important therapeutic advance.

In clinical trials, no safety concerns have been reported in over 1,000 human subjects exposed to Locilex™. Importantly, no antimicrobial resistance, or cross resistance with other antibiotics, has been noted to date. Because Locilex™ does not absorb beneath the subdermal layer of the skin, systemic resistance to the drug cannot develop, unlike virtually all other currently available antibiotics.

If FDA approved, Locilex™ would become the first topical antibiotic approved for the treatment of diabetic foot infection of any severity (mild, moderate or severe DFI).     

About Mild Infections of Diabetic Foot Ulcers

It is estimated that Mild Infections of Diabetic Foot Ulcers occur in approximately 1.5 million patients per year in the United States and constitute approximately one-half of the patients who first present with mild, moderate or severe Diabetic Foot Infection each year.  The worldwide market for Diabetic Foot Infection (mild, moderate and severe DFI) is estimated at approximately $1.5 billion in 2011 and is estimated to continue growing through at least 2019.  Currently, there are no antibiotics, systemic or topical, which are FDA approved for the treatment of Mild Infections of Diabetic Foot Ulcers.  We believe currently used antibiotics for this indication are either overly invasive for the infection being treated, cause systemic resistance and generate resistant bacteria or involve safely and toxicity issues needlessly if a topical, non-invasive yet effective antibiotic were to be approved and become a viable treatment option available for treating physicians. Accordingly, we believe Locilex™ may constitute a significant therapeutic advance in the treatment of Mild Infections of Diabetic Foot Ulcers.  

About Dipexium:

Founded in January 2010, Dipexium Pharmaceuticals, LLC is an emerging biotechnology company formed to develop and commercialize Locilex™ (pexiganan acetate cream 1%), a novel, broad spectrum, small peptide topical antibiotic for the treatment of certain mild and moderate skin infections in superficial wounds. Initially, Locilex™ is targeted for the treatment of mild infections of diabetic foot ulcers. Based on a compilation of available clinical and pre-clinical data, Locilex™ is also considered a promising product candidate, to treat mild or moderate acute bacterial skin and skin structure infections (ABSSSI) in superficial wounds, including infected decubitus ulcers, infected burns, infected surgical wounds and nasal colonization of methicillin-resistant staphylococcus aureus (MRSA).

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1, Phase 2 and/or Phase 3 clinical trials, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult their financial, legal and other professional advisors for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.

Contact:

For additional information about Dipexium Pharmaceuticals or Locilex™, please visit: www.dipexiumpharmaceuticals.com or contact the Company as follows:

David P. Luci
Co-Founder & Managing Partner
Tel: +1-917-533-1469
Email:  davidluci@dipexium.com