Dalbavancin (Durata Therapeutics) success in Phase III DISCOVER 2 trial for ABSSSI

Durata Therapeutics, Inc. has announced preliminary, top-line results for its DISCOVER 2 ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response") Phase III 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 methicillin resistant Staphylococcus aureus (MRSA). DISCOVER 2 results follow the recent release of data from DISCOVER 1, which also met its primary and secondary endpoints.

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 trial assessed as a secondary outcome measure the non-inferiority of clinical response at the end of treatment in clinically evaluable patients. Dalbavancin also achieved this secondary endpoint.

The DISCOVER 2 study was conducted pursuant to a special protocol agreement (SPA) with the FDA based on the FDA's Draft Guidance for Developing Drugs for Treatment of ABSSSI.