Durata Therapeutics Completes Target Enrollment in Phase 3 DISCOVER 2 Clinical Trial Comparing Dalbavancin to Vancomycin and Linezolid in ABSSSI Patients
Milestone Achieved On Schedule, NDA Filing on Track for Q2 2013
MORRISTOWN, N.J.--(BUSINESS WIRE)-- Durata Therapeutics (NAS: DRTX) today announced that it has completed its target enrollment for DISCOVER 2 ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response"), the second global, Phase 3 clinical trial of Durata's lead product candidate, dalbavancin, under investigation for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria.
DISCOVER 2 is a randomized, double-blind, double-dummy trial comparing the efficacy of dalbavancin to a regimen of vancomycin for the treatment of ABSSSI. Researchers are comparing two intravenous doses of dalbavancin given one week apart with twice daily vancomycin doses for 14 days. Patients randomized to the vancomycin regimen have an option to switch to oral linezolid after three days of vancomycin treatment.
As with DISCOVER 1, the protocol design of DISCOVER 2 is consistent with FDA's Draft Guidance for Developing Drugs for Treatment of ABSSSI. This pivotal study is being conducted pursuant to a special protocol agreement with the U.S. Food and Drug Administration, and is also designed based on scientific advice provided by the European Medicines Agency (EMA).
"With the completion of patient enrollment for our DISCOVER 2 pivotal trial on schedule, we believe we are on track for submitting our New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the first half of 2013," said Durata Chief Executive Officer Paul R. Edick.
The primary outcome measure of DISCOVER 2 is a comparison of clinical response to therapy measured 48-72 hours after initiation of therapy determined by the cessation of spread of the erythema (redness) associated with the lesion, as well as the resolution of fever. The study, at 139 sites in the United States, Europe, Asia and South Africa, targeted enrollment of 740 patients.
Additional information regarding the trial can be found on clinicaltrials.gov.
Dalbavancin is an intravenous antibiotic product candidate under investigation for once-weekly dosing, which we believe may facilitate the treatment of patients with ABSSSI in both the in-patient and out-patient settings, potentially reducing the length of a patient's hospital stay or avoiding hospital admission altogether, with an impact on the overall cost of care for these patients.
Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses. Durata has completed enrollment in two global Phase 3 clinical trials with its lead product candidate, dalbavancin, for the treatment of patients with acute bacterial skin and skin structure infections, or ABSSSI.
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