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news.Arpida has reported positive top-line data of the Phase II 'intravenous-to-oral' switch trial with oral iclaprim in patients with complicated skin and skin structure infections.
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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.