Durata Therapeutics completes dalbavancin Phase 3 trials on ABSSSI

Sep 11 2012

Durata Therapeutics (NASDAQ: DRTX) today announced results from its QT study of the company's lead product candidate, dalbavancin. Dalbavancin is currently under investigation in two ongoing, global, Phase 3 clinical trials for the treatment of acute bacterial skin and skin structure infections (ABSSSI). The QT study data, presented at the 52^nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), showed that in this study dalbavancin had no clinically significant impact on cardiac conduction.

The U.S. Food and Drug Administration (FDA) generally requires thorough QT studies for new chemical entities due to the risk of heart arrhythmias associated with some pharmaceutical products. The results observed in Durata's definitive study are intended to satisfy the FDA's requirements in this area. These data will be included in the company's New Drug Application (NDA) for dalbavancin, which Durata anticipates submitting with the FDA in the first half of 2013.