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Skin-Infection Antibiotic Dalbavancin Meets Primary Endpoint in Phase III Trial

Drug non-inferior to vancomycin (Jan. 4)

Additional preliminary results have been announced from the DISCOVER 1 (Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response) phase III study of the antibiotic candidate dalbavancin (Durata Therapeutics), which is under investigation for the treatment of acute bacterial skin and skin-structure infections (ABSSSIs) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

Previous data — reported on December 11, 2012 — showed that dalbavancin achieved its primary endpoint of non-inferiority at 48 to 72 hours after initiation of therapy versus vancomycin, as determined by the cessation of lesion spread and by the resolution of fever. A subpopulation of patients with MRSA at baseline achieved similar results.

DISCOVER 1 was a randomized, double-blind, double-dummy trial involving 573 patients at sites in the U.S., Canada, and Europe. The researchers compared two intravenous doses of dalbavancin given 1 week apart with twice-daily vancomycin doses for 14 days. Patients randomized to the vancomycin regimen had the option of switching to oral linezolid after 3 days of vancomycin treatment.

In the updated findings, an early response (48 to 72 hours after initiation of therapy) was observed in 240 of 288 patients (83.3%) treated with dalbavancin compared with 233 of 285 patients (81.8%) treated with vancomycin/linezolid. Similarly, in the subgroup of patients with MRSA, an early response was noted in 37 of 44 patients (84.1%) treated with dalbavancin versus 32 of 39 patients (82.1%) treated with vancomycin/linezolid.

Source: Durata Therapeutics; January 4, 2013.

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