- Dipexium Pharmaceuticals (NASDAQ:DPRX) hits its enrollment target of ~180 subjects in one of its two parallel Phase 3 studies, called OneStep-2, evaluating topical antibacterial Locilex (pexiganan cream 0.8%) for the treatment of patients with mild infections of diabetic foot ulcers. Participants are being randomized 1:1 to receive Locilex plus standard local wound care or placebo cream plus standard local wound care for 14 days. The primary endpoint is clinical response as determined by the investigator by day 28. Top-line data are expected in Q3.
- The other Phase 3, OneStep-1, is 98% enrolled. If both trials are successful, regulatory submissions are planned in the U.S. and EU for H1 2017.
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Pexiganan is a chemically synthesized peptide isolated from the skin of the African Clawed Frog. Its bactericidal mechanism of action is disrupting cell membrane permeability which makes its effective across a broad range of Gram-positive and Gram-negative aerobic and anerobic bacteria in addition to fungi. It also does not absorb into the bloodstream which allows for the delivery of a higher concentration of antibiotic to the infected area.
- Most antibiotics work by inhibiting the replication of bacteria which makes long-term efficacy difficult to maintain due to the bacteria's relentless evolution to develop resistance to the drug.