IV delafloxacin: Additional Phase III data

Additional data from the double-blind, international Phase III Study RX-3341-302 in 660 patients with ABSSSIs showed that 300 mg IV delafloxacin given every 12 hours for 5-14 days led to an objective response in 78.2% of patients, defined as a >=20% reduction in lesion seize with no further antibiotics, major procedures or death, at 48-72 hours -- the FDA-defined primary endpoint -- vs. 80.9% of patients receiving vancomycin plus aztreonam. In clinically evaluable patients (n=591), the response rate was 85% for delafloxacin vs. 86.5% for vancomycin plus aztreonam. On the EMA-defined secondary endpoint of investigator assessment of signs and symptoms of infection, delafloxacin led to a cure rate of 52% at the follow-up visit at day 14 and 70.4% at the late follow-up visit on day 21-28 vs. 50.5% and 66.6%, respectively, for vancomycin plus aztreonam. Data were presented at the IDWeek meeting in San Diego. Melinta previously reported top-line data showing that delafloxacin met the FDA-defined primary endpoint (see BioCentury, Jan. 19). ...