Dipexium Pharmaceuticals is a late stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a potent and broad spectrum topical antibiotic peptide, for the treatment of mild and moderate skin and skin structure infections.
Our primary objective is to establish Locilex® as the standard of care for the treatment of mild infections of diabetic foot ulcers (Mild DFI), an indication for which there are currently no products specifically approved by the U.S. Food and Drug Administration (FDA). We are conducting two pivotal Phase 3 clinical trials in Mild DFI, OneStep-1 and OneStep-2. These trials are designed to establish the clinical superiority and safety of Locilex® plus standard local wound care (debridement and off-loading) as compared to placebo cream plus standard local wound care, in the treatment of Mild DFI. We have agreed to a Special Protocol Assessment with the FDA on our Phase 3 Mild DFI program.
Mild DFI is one of many types of skin and skin structure infections. Our growth strategy includes expanding Locilex®'s approved indications to include moderate infections of diabetic foot ulcers (Moderate DFI), as well as other mild or moderate skin and skin structure infections, including, but not limited to, infected surgical wounds, infected burns, and infected decubitus ulcers (pressure sores). As an antimicrobial peptide, with a unique mechanism of action, Dipexium believes Locilex® has the potential become an ideal front-line treatment option for patients with mild and moderate skin and skin structure infections.
Dipexium Pharmaceuticals has built an exceptional executive team and network of expert consultants that combined, has successfully guided over a dozen products through clinical development, global regulatory approvals, and commercialization.