Cubist Launches Antibiotic Drug Phase 3 Trial
The trial is the first of two planned multicentre, global, double-blind, randomised Phase 3 studies to compare the safety and efficacy of CXA-201.
Biopharmaceutical company Cubist Pharmaceuticals, Inc. announced this week the initiation of a pivotal Phase 3 trial of the CXA-201 drug in patients with complicated urinary tract infections (cUTI).
CXA-201 will be used as a first-line intravenous therapy for the treatment of serious Gram-negative bacterial infections, including those caused by multidrug-resistant Pseudomonas aeruginosa.
The trial is the first of two planned multicentre, global, double-blind, randomised Phase 3 studies to compare the safety and efficacy of CXA-201 versus levofloxacin in patients with cUTI. The primary objective is to establish non-inferiority of CXA-201 to the comparator with respect to the proportion of patients in the modified microbiological in
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