(NASDAQ: DRTX) today announced that it has completed its target enrollment for DISCOVER 1 (“
nfections of the
ancomycin at an
esponse”), 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The protocol design of DISCOVER 1 is consistent with FDA Draft Guidance for Developing Drugs for Treatment of abSSSI.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.