Dipexium Says Phase 3 Trials With Locilex Fails To Meet Primary Endpoint

(RTTNews) - Dipexium Pharmaceuticals Inc. (DPRX) said Tuesday that the OneStep-1 and OneStep-2 Phase 3 clinical trials of Locilex (pexiganan cream 0.8%) in patients with mild infections of diabetic foot ulcers or Mild DFI did not meet the primary clinical endpoint of superiority versus vehicle plus standardized wound care and also did not show any meaningful difference in wound closure rate between the Locilex arm and the vehicle arm in each study. Neither trial met the secondary endpoint of demonstrating a higher rate of eradication of bacteria for the Locilex arm.

While the overall adverse event incidence was comparable to vehicle alone, serious adverse events with Locilex included higher than anticipated osteomyelitis and cellulitis in the Locilex arm of each study.

David Luci, President & CEO of Dipexium, said, "Although we are disappointed with these results, we are continuing to evaluate the data and will consider potential regulatory pathways forward in other possible clinical indications based on an evaluation of all data emerging from the Phase 3 studies."