The company said that the top-line results demonstrated high clinical cure rates of over 90% following the step-down therapy with oral iclaprim administered after two days of initial treatment with intravenous vancomycin.
In the per protocol population, 27/29 patients in the oral iclaprim arm were cured, as compared to 28/28 following continuous treatment with intravenous vancomycin.
Eradication rates for Staphylococcus aureus, the major causative pathogen, were high with 85% in the oral iclaprim arm, and similar to intravenous vancomycin (89%). Iclaprim was well tolerated; adverse events were infrequent and not significantly different between both study arms. Importantly, no drug-related serious adverse events occurred and there were no patient withdrawals due to adverse events, the company said.