Dipexium Pharmaceuticals Reports 2015 Financial Results

Dipexium Pharmaceuticals, Inc. (Nasdaq:DPRX) announced operational and financial results for the year ended December 31, 2015.
According to the news:

Recent Highlights and Developments

• Clinical Development:  As of today, our pivotal Phase 3 clinical trials, OneStep-1 and OneStep-2, have both passed the 85% enrollment mark, with approximately the same number of patients enrolled in each trial. These trials target enrollment of 180 patients per trial, for a total of 360 patients. The OneStep pivotal Phase 3 clinical trials are designed 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.  We anticipate completing enrollment in these studies in the second quarter of 2016 and announcing top-line data in the third quarter of 2016.

• Microbiology:  In 2015, management finalized protocols for five new microbiology studies to be conducted in the first half of 2016. These microbiology studies are intended to strengthen our planned regulatory submissions with the U.S. Food and Drug Administration (FDA) and EMA and will provide supportive information for inclusion in the clinical and in vitro list for proposed drug labeling in the U.S. and Europe.

• Regulatory:
  • Pediatric Waivers: In the first quarter of 2016, we received formal agreement from FDA and EMA with regard to the Company’s initial pediatric study plan, pursuant to which the regulatory authorities both agreed that pediatric studies are not required to be performed by the Company at this time.
  • EU Regulatory Pathway:  In May 2015, the Company obtained formal scientific and regulatory advice from EMA’s Committee for Medicinal Products for Human Use (CHMP), regarding the requirements for obtaining a marketing authorization for Locilex in the EU.  On the basis of this formal advice, management believes the Company will be in position to submit our marketing authorization application to EMA in the first half of 2017 without being required to conduct additional clinical trials in Europe in support of our submission.

• Manufacturing:
  • The Company’s manufacturer of the active pharmaceutical ingredient (API) has now completed the first of three validation lots of API that we will need for our planned submission of a new drug application amendment to FDA and marketing authorization application to EMA.  We are planning to initiate the manufacture of the two remaining validation lots per regulatory guidelines, and these tasks will be performed starting in the first half of 2016.
  • We also have scaled up the size of our API lots and have successfully completed a scale-up of the first formulated batch of Locilex cream at the 140 kg size.  We are using this inventory in the OneStep Phase 3 trials.  This 140 kg batch size is also the size to be used for initial commercial-scale inventory for product market introduction.
  • In addition, we have now successfully manufactured, and put on stability, a 2 g tube of Locilex to be used as physician samples to support market introduction.

• Financial Position:  In June 2015, we announced the closing of our secondary public offering of common stock, raising gross proceeds of $21.3 million. We believe this additional capital enables us to complete the OneStep pivotal Phase 3 clinical trials, potentially file our regulatory submissions for approval in the U.S. and EU, and to expand our development and commercialization efforts in Europe, Japan, and other areas of the world.

• Intellectual Property: In the first quarter of 2016, the Company announced the issuance of Locilex patents in Australia and New Zealand.  Management anticipates the issuance of additional international patents throughout 2016 and 2017.  These may include new international patents arising from ongoing prosecutions in Canada, China, Europe, Japan, Korea, Latin America and South America.

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