Oritavancin: Phase III data

In patients with microbiologically-confirmed methicillin-resistant Staphylococcus aureus (MRSA) infection (n=201), 82% of patients receiving oritavancin achieved an early clinical response vs. 81.2% for vancomycin. Additionally, the proportion of patients in the subgroup with a >20% reduction in lesion area at 48-72 hours was 96% in the oritavancin arm vs. 90.1% in the vancomycin arm. Furthermore, 84% of patients in the oritavancin arm achieved investigator-assessed clinical cure vs. 85.1% for vancomycin. The proportion of patients who experienced >=1 adverse event was similar between treatment groups (50.9% vs. 50.2%).

Last December, the company reported data from the identical Phase III SOLO I trial in 968 patients with ABSSSI showing that oritavancin met the FDA- and EMA-defined primary endpoints of non-inferiority to vancomycin (see BioCentury, Dec. 24, 2012). Pooled data from patients with microbiologically-confirmed MRSA infection from both the SOLO I and II trials (n=405) showed that 81.4% of patients receiving oritavancin achieved an early clinical response vs. 80.6% for vancomycin. Additionally, the proportion of patients in the subgroup with a >20% reduction in lesion area at 48-72 hours was 93.1% in the oritavancin arm vs. 87.1% in the vancomycin arm. Furthermore, 83.3% of patients in the oritavancin arm achieved investigator-assessed clinical cure vs. 84.1% for vancomycin. The Medicines Co., which has an SPA from FDA for the trials, said the protocols pre-specified that MRSA patients from the SOLO trials would be pooled for an evaluation of efficacy. ...