Durata Therapeutics Completes Target Enrollment in Phase 3 DISCOVER 2 Clinical Trial Comparing Dalbavancin to Vancomycin & Li...
October 25 2012 - 7:45AM
Business Wire
Durata Therapeutics (NASDAQ: 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consistent with FDA’s Draft Guidance for Developing Drugs for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.
About Dalbavancin
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.
About Durata Therapeutics
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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