MDCO reports first Phase III data for ABSSI compound

The Medicines Co. (NASDAQ:MDCO) said a single dose of IV oritavancin met the FDA-defined and EMA-defined primary endpoints of non-inferiority to twice-daily vancomycin for 7-10 days in the 968-patient Phase III SOLO-1 trial to treat acute bacterial skin and skin structure infection (ABSSSI). Specifically, oritavancin was non-inferior to vancomycin on the FDA-defined endpoint of the proportion of patients with an early clinical response, defined as cessation of spread of the lesion, absence of fever and no rescue antibiotics at 48-72 hours after treatment start. Oritavancin was also non-inferior to vancomycin on the EMA-defined endpoint of the proportion of patients with investigator-assessed clinical cure at 7-14 days after the end of treatment. ...