Phase 3 Study of Dalbavancin for Acute Bacterial Skin and Skin Structure Infections Begun

According to a Durata Therapeutics press release, the company has initiated a global, pivotal, Phase 3 study (DISCOVER-1) of its lead product, dalbavancin, a long-acting, intravenous (IV) lipoglycopeptide for the treatment of acute bacterial skin and skin structure infections (abSSSI). The pivotal, Phase 3 study is a randomized, double-blind, double-dummy study designed to compare the efficacy and safety of dalbavancin to vancomycin, with patients randomized to vancomycin allowed to switch to oral linezolid after 3 days of IV vancomycin therapy. It is being conducted under a Special Protocol Assessment agreed upon with the U.S. Food and Drug Administration. The study is expected to enroll approximately 556 patients worldwide. Patients will be randomized to receive either two doses of dalbavancin — each infused over 30 minutes, 1 week apart from each other — or 10 to 14 days of the comparator regimen. Clinical response will be measured at 48 to 72 hours post study initiation and again at study day 14-15. These measures are consistent with current draft FDA guidance for the development of antibiotics. Durata's Chief Medical Officer, Michael Dunne, MD, stated, "Dalbavancin is one of the most advanced of the next-generation lipoglycopeptides, in the same class as vancomycin. In a previous, Phase 3 study, dalbavancin met its primary endpoint for the treatment of complicated skin infections. Due to its unique features and PK profile, dalbavancin offers the significant convenience of once-a-week dosing and short, 30-minute infusion time. Furthermore, the safety profile of dalbavancin already has been established in extensive previous clinical development work in over 1300 patients. Based on these characteristics and our expectations for the pivotal program, we believe this product has the potential to set the bar for activity against important Gram-positive bacterial infections, including those due to MRSA."