Durata Therapeutics, Inc. (NASDAQ: DRTX) today announced preliminary, top-line results for its DISCOVER 1 (“ 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 MRSA (methicillin resistant Staphylococcus aureus).
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 key secondary endpoints were supportive of the primary endpoint.
The DISCOVER 1 protocol 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pursuant to a special protocol agreement (SPA) with the U.S. Food and Drug Administration (FDA) based on the FDA’s Draft Guidance for Developing Drugs for Treatment of ABSSSI.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 1 was a randomized, double-blind, double-dummy trial conducted in 573 patients at 92 sites in the United States, Canada, and Europe comparing dalbavancin to a regimen of vancomycin and an option for oral linezolid for the treatment of ABSSSI.
|Top-Line Data from DISCOVER 1 Trial|
|Primary Endpoint, Early Response (48-72 hours)|
|Dalbavancin||Vancomycin/Linezolid||Difference in point estimates (95% Confidence Interval)|
|Early Response (ITT)||239/288 (83.0%)||233/285 (81.8%)||1.2% (-4.9, 7.6)|
|Secondary Endpoint, End of Treatment, Day 14|
|Clinical Status (CE)||214/246 (87.0%)||222/243 (91.4%)|
|Clinical Status (ITT)||236/288 (81.9%)||247/285 (86.7%)|
ITT = Intent to Treat; CE = Clinically Evaluable
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