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news.Durata Therapeutics has started a randomized, double-blind, double-dummy Phase 3 (DISCOVER-1) study to investigate intravenous (IV) lipoglycopeptide dalbavancin as a tretament for acute bacterial skin and skin structure infections (ABSSSI).
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The trial is planned to investigate the safety and efficacy of dalbavancin to vancomycin, with patients randomized to vancomycin allowed to switch to oral linezolid after three days of IV vancomycin therapy.
Earlier, in a Phase 3 trial dalbavancin met its primary endpoint for the treatment of complicated skin infections.
Durata CEO Paul Edick said the data from this trial, supplemented by a previously completed, Phase 3 study, will provide the basis of the overall clinical program, leading to their regulatory submission to the FDA.
"The SPA agreement is an important element in this, since it maps out a clearly defined path forward, concurrent with the FDA’s process of finalizing its guidelines for antibiotic development for acute bacterial skin and skin structure infections," Edick said.