Polyphor announces protocol agreement with the FDA for the second pivotal Phase III study of murepavadin
Polyphor has started PRISM-UDR Phase III clinical trial of the pathogen-specific antibiotic murepavadin in patients with nosocomial pneumonia and expects to begin recruitment by Q119.
Polyphor announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) on protocol for its PRISM-UDR Phase III clinical study of murepavadin. The study has started with the first centers being enrolled. The study evaluates murepavadin for the treatment of nosocomial pneumonia due to Pseudomonas aeruginosa. Polyphor expects to recruit the first patient by Q119.