Durata commences dalbavancin Phase 3 study in acute bacterial skin and skin structure infections

Durata Therapeutics today announced the Company 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 study is being conducted under a Special Protocol Assessment (SPA) agreed upon with the U.S. Food and Drug Administration (FDA).

Paul R. Edick, Chief Executive Officer of Durata, commented, "We are very pleased to begin this pivotal clinical study for dalbavancin, which Durata acquired in December 2009. The data from this trial, supplemented by a previously completed, large Phase 3 study, will provide the basis of our overall clinical program, leading to our 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. We look forward to continued momentum in our program in the near term."

John E. Edwards, Jr., M.D., Chief, Division of Infectious Diseases, Harbor/UCLA Medical Center, Professor of Medicine, David Geffen School of Medicine at UCLA, said, "New antibiotics with activity against resistant staphylococci are critically needed. Antibiotic resistance is a growing concern; for instance, community-acquired methicillin-resistant Staphylococcus aureus (MRSA) has now become a common cause of community-acquired soft tissue infections at many clinical care centers. Physicians need new products so that we can address the increasing threat to health of patients both inside and outside the hospital setting."

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 three days of IV vancomycin therapy. 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, one 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, M.D., 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."