Durata Therapeutics has completed its target enrollment for DISCOVER 1, 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. DISCOVER 1 is a 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. The protocol design of DISCOVER 1 is consistent with FDA Draft Guidance for Developing Drugs for Treatment of abSSSI.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 FDA and is based on scientific advice provided by the European Medicines Agency.
Happy demi-anniversary, stock market rally. Will the honeymoon ever end?