Phase III trials failure for Locilex (pexiganan cream 0.8%) to treat diabetic foot ulcers.- Dipexium Pharmaceuticals.

Dipexium Pharmaceuticals, Inc. announced that the OneStep-1 and OneStep-2 Phase III clinical trials of Locilex (pexiganan cream 0.8%) in patients with mild infections of diabetic foot ulcers (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.