PolyMedix has initiated a Phase II clinical trial of PMX-30063, its novel defensin-mimetic antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by Staphylococcus aureus.
PMX-30063 is a systemic antibiotic that mimics the activity of human host-defence proteins, the body’s natural defence against bacterial infections.
The blind, active-controlled and randomised study is designed to evaluate the safety and efficacy of PMX-30063 as an initial treatment for ABSSSI.
Around 200 patients with ABSSSI will be enrolled and randomised to receive one of three doses of PMX-30063 or daptomycin, the active control.
Patients in the PMX-30063 groups will be administered once-daily PMX-30063 in its intravenous form for five days followed by two days of placebo, while patients in the daptomycin group will receive once-daily daptomycin for seven days.
The trial will be conducted at multiple centres across Canada and the results are expected in mid-2011.
