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Durata Therapeutics Announces Preliminary, Topline Phase 3 Clinical Trial Results For Dalbavancin In The Treatment Of ABSSSI

Stocks in this article: DRTX

DISCOVER 2 Study Meets Primary & Secondary Endpoints Conference Call and Webcast Today at 8:30 A.M. EST to Discuss Results

CHICAGO, Feb. 25, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX) today announced preliminary, top-line results for its DISCOVER 2 (" D albavancin for I nfections of the S kin CO mpared to V ancomycin at an E arly R esponse") Phase 3 study of dalbavancin, which is under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA). DISCOVER 2 results follow the recent release of data from DISCOVER 1, which also met its primary and secondary endpoints.

Preliminary top-line data show that dalbavancin achieved its primary endpoint of non-inferiority (10% non-inferiority margin) at 48-72 hours after initiation of therapy, as determined by the cessation of spread of the lesion, as well as the resolution of fever. Researchers were comparing two intravenous (IV) doses of dalbavancin given one week apart with twice-daily vancomycin doses for 14 days. Patients randomized to the vancomycin regimen had an option to switch to oral linezolid after three days of vancomycin treatment. In addition, the trial assessed as a secondary outcome measure the non-inferiority of clinical response at the end of treatment in clinically evaluable patients. Dalbavancin also achieved this secondary endpoint.

The DISCOVER 2 study was conducted pursuant to a special protocol agreement (SPA) with the U.S. Food and Drug Administration (FDA) based on the FDA's Draft Guidance for Developing Drugs for Treatment of ABSSSI. The protocol for the trial was also designed based on scientific advice provided by the European Medicines Agency (EMA). DISCOVER 2 was a randomized, double-blind, double-dummy trial conducted in 739 patients at 139 sites in the United States, Europe, Asia and South Africa comparing dalbavancin to a regimen of vancomycin (with an option to switch to oral linezolid) for the treatment of ABSSSI.

Top-line Data from the DISCOVER 2 Trial
  Endpoint Dalbavancin Vancomycin/ linezolid Difference in point estimates (95% Confidence interval)
FDA Primary Endpoint Early response 48-72 hours 285/371 (76.8%) 288/368 (78.3%) -1.5% (-7.4, 4.6)
  >20% reduction in  lesion size 325/371 (87.6%) 316/368 (85.9%) 1.7% (-3.2, 6.7 )
FDA Secondary Endpoint  (EMA Primary Endpoint) Clinical Status 1 End of Treatment 303/324 (93.5%) 280/302 (92.7%) 0.8% (-3.3, 4.9)
  Investigators' assessment 314/324 (96.9%) 290/302 (96.0%) 0.9% (-2.2, 4.1)
         
1Pre-specified adjustment to the confidence interval by important baseline variables        

In this clinical trial, the drug-related treatment-emergent adverse event rate for dalbavancin was 12.2% and for vancomycin/linezolid was 10.1%. The most commonly reported adverse events for dalbavancin in this trial were nausea, diarrhea, vomiting, pruritus and headache. Discontinuations due to treatment emergent adverse events were 2.4% and 1.9% for dalbavancin and vancomycin/linezolid, respectively. This adverse event profile is consistent with results from prior Phase 3 studies and DISCOVER 1. Additional analyses of the data are ongoing.

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