Iclaprim: Ph III REVIVE-1 data

Top-line data from the double-blind, international Phase III REVIVE-1 trial in 598 patients with ABSSSIs showed that 80 mg IV iclaprim every 12 hours for 5-14 days met the primary endpoint of non-inferiority to vancomycin in early clinical response, defined as the proportion of patients achieving a ≥20% reduction in lesion area at early time point 48-72 hours after the start of treatment (80.9% vs. 81%). The non-inferiority margin was 10%. Iclaprim was also non-inferior to vancomycin in the proportion of patients achieving clinical cure at the TOC visit 7-14 days after the end of treatment (84.2% vs. 87%). On secondary endpoints, iclaprim led to lesion resolution or near resolution at the end of treatment in 60.4% of patients vs. 58.3% of patients receiving vancomycin. Iclaprim also led to a modified clinical cure rate of 68.5% vs. 73% for vancomycin. Modified clinical cure was defined as a achieving a >90% reduction in lesion size at the TOC visit with no increase in lesion size after the early time point and no requirement for additional antibiotics. Iclaprim was well tolerated. Data from the identical Phase III REVIVE-2 trial of iclaprim are expected next half...