Milestone Achieved On Schedule Through Collaborative Efforts of 92 Study Sites
MORRISTOWN, N.J.--(BUSINESS WIRE)--Durata Therapeutics (NASDAQ: DRTX) today announced that it has completed its target enrollment for DISCOVER 1 (“Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response”), one of two ongoing, global, Phase 3 clinical trials of Durata’s lead product candidate, dalbavancin, under investigation for the treatment of acute bacterial skin and skin structure infections (abSSSI).
DISCOVER 1 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.
The protocol design of DISCOVER 1 is consistent with FDA Draft Guidance for Developing Drugs for Treatment of abSSSI.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 based on scientific advice provided by the European Medicines Agency (EMA).
“We are pleased to have achieved this milestone on schedule, with an open enrollment of less than 18 months, and in under three years since our inception. This accomplishment reflects our strong organizational focus to offer clinicians an important and valuable alternative to currently available Gram-positive intravenous (IV) antibiotic therapies,” said Durata Chief Executive Officer Paul R. Edick.
The primary endpoint of DISCOVER 1 is the early response to therapy measured 48-72 hours after initiation of therapy and determined by the cessation of spread of the erythema (redness) associated with the lesion, as well as the resolution of fever. The study targeted enrollment of 556 patients.
“Durata is conducting this Phase 3 pivotal clinical trial at 92 sites in the United States, Canada and Europe. We greatly appreciate the efforts of the site investigators, and the patients participating in the trial, in helping us reach this milestone within our projected timeframe,” said Durata Chief Medical Officer Michael Dunne, M.D.
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.
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 is currently enrolling and dosing patients 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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