Durata Therapeutics, Inc (DRTX)

[Norm]

Spa + working with Ema. With offering out of the way, low float, and offering out of the way this set to move in a few weeks. Starter@ 7.25

7:01AM Durata Therapeutics announces preliminary, topline phase 3 clinical trial results for dalbavancin in the treatment of ABSSSI; DISCOVER 2 study meets primary & secondary endpoints (DRTX) 7.41 : 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pursuant to a special protocol agreement (SPA) with the U.S. Food and Drug Administration (FDA) based on the FDA's Draft Guidance for Developing Drugs for Treatment of ABSSSI. The protocol for the trial was also designed based on scientific advice provided by the European Medicines Agency (EMA).

The most commonly reported adverse events for dalbavancin in this trial were nausea, diarrhea, vomiting, pruritus and headache. Discontinuations due to treatment emergent adverse events were 2.4% and 1.9% for dalbavancin and vancomycin/linezolid, respectively. This adverse event profile is consistent with results from prior Phase 3 studies and DISCOVER 1. Additional analyses of the data are ongoing.