Dalbavancin meets endpoint in second Phase III ABSSI trial

Durata Therapeutics Inc. (NASDAQ:DRTX) said IV dalbavancin met the FDA-defined and EMA-defined primary endpoints of non-inferiority to twice-daily vancomycin in the 739-patient Phase III DISCOVER 2 trial to treat acute bacterial skin and skin structure infections (ABSSSI). The FDA-defined primary endpoint was non-inferiority to twice-daily vancomycin in the proportion of patients in the intent-to-treat (ITT) population with an early response defined as cessation of spread of the lesion and resolution of fever at 48-72 hours after treatment start (76.8% vs. 78.3%, 95% CI: -7.4, 4.6). The EMA-defined primary endpoint was non-inferiority to vancomycin and/or linezolid in the proportion of patients with clinical success based on lesion size, local signs and temperature at end of treatment day 14 (93.5% vs. 92.7%, 95% CI: -3.3, 4.9). Patients received a single 1,000 mg dose of dalbavancin followed by a 500 mg dose given one week later or twice-daily vancomycin for 14 days.

Durata previously reported that dalbavancin met both the FDA- and EMA-defined primary endpoints in the Phase III DISCOVER 1 trial in the indication. The company, which has SPAs from FDA for the trials, plans to submit an NDA to FDA in mid-2013 and an MAA to EMA by year end. Durata gained the second-generation once-weekly glycopeptide antibiotic through its 2009 acquisition of Vicuron Pharmaceuticals Inc., which was a subsidiary of Pfizer Inc. (NYSE:PFE) (see BioCentury Extra, Dec. 11, 2012). ...