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ARTICLE | Clinical News

Durata's dalbavancin meets endpoint in Phase III ABSSSI trial

December 12, 2012 2:54 AM UTC

Durata Therapeutics Inc. (NASDAQ:DRTX) said IV dalbavancin met the FDA-defined primary endpoint of non-inferiority to twice-daily vancomycin in the 573-patient Phase III DISCOVER 1 trial to treat acute bacterial skin and skin structure infections (ABSSSI). Specifically, dalbavancin was non-inferior to vancomycin in the proportion of patients in the intent-to-treat (ITT) population with an early response defined as cessation of spread of the erythema of the lesion and resolution of fever at 48-72 hours after treatment start (83% vs. 81.8%, 95% CI: -4.9, 7.6).

The proportion of clinically evaluable patients (n=489) with clinical status success based on lesion size, local signs and temperature at end of treatment day 14, the EMA-defined primary endpoint, was 87% in the dalbavancin arm vs. 91.4% in the control arm. In 1Q13, Durata expects to report statistical data for the confidence interval of the EMA-defined primary endpoint. 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. ...