Durata Data on Dalbavancin Shows Primary Endpoints Met

Durata Therapeutics, Inc.

today announced a comprehensive review of the efficacy, safety and microbiology data of the company's lead product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI). The data is being presented in six posters at this year's IDWeek 2013™, held in San Francisco, Calif., October 2-6, 2013. Among the findings, an integrated analysis of two Phase 3 clinical studies (DISCOVER 1 and 2) showed dalbavancin met its primary and secondary endpoints of early response, measured at 48 to 72 hours of therapy, as well as clinical success at the end of treatment. Sensitivity analyses for both timepoints were also included.i A separate analysis showed that patients achieving cessation of spread of the lesion after 72 hours of antibiotic treatment with dalbavancin have a greater than 90 percent chance of being cured at the end of treatment.ii A pooled summary analysis of the safety profile of dalbavancin based on the Phase 2 and 3 clinical program also found it to be generally well-tolerated and to have a similar safety profile to comparators with fewer adverse events.iii Examination of patients with baseline