Dipexium Pharmaceuticals Inc (NASDAQ:DPRX) has announced that its phase-3 clinical trials of Locilex, aimed at the treatment of mild infections of diabetic foot ulcers, has failed to meet its primary endpoints. The study had been designed to determine the superiority of Locilex, as compared to standardized wound care. The company noted that the study had not found any meaningful difference in wound closure rate, between the two populations. The secondary endpoint of the study was to observe a higher rate of eradication of bacteria, which was not, met either.
The CEO of Dipexium, David P. Luci, expressed his disappointment at the results and stated that they would evaluate the data and determine potential regulatory pathways for other possible indications. Following the announcement, investors began dumping the stock as it experienced a sharp decline of over 70%, in its share value, on October 24. The chairman of the trials, Benjamin A. Lipsky MD, stated that the diabetic foot is a complex problem, but the trial had generated a lot of data, which would help better interpret the outcome.
Mr. Lipsky also lauded the efforts of the company, stating that in over 30-years of conducting DFI trials, he has never seen such a careful and diligent approach. He expressed his optimism by stating that the data might be useful to better understand the problems associated with DFI and may even lead to recognition that some DFI patients may not require anti-bacterial treatments. It should be noted here that Locilex was the flagship product of DPRX and the current results are a major setback for the company.
Earlier this month, Dipexium was granted the designation of Small and Medium Enterprise, by the European Medicines Agency. The designation had originally been developed, to promote development and innovation, of new pharmaceutical products by small companies. Being an SME entitles DPRX to receive financial incentives, as well as admin and regulatory support through different programs.
Dipexium Pharmaceuticals Inc (NASDAQ:DPRX) lost 78.04% of its share value, during the October 25 trading session, to close at $2.8 per share. The stock had a trade volume of 21.98 millon.