Polyphor announces enrollment of first patient in PRISM-UDR - the second, FDA agreed - Phase III clinical trial for murepavadin in patients with nosocomial pneumonia
Polyphor AG / Key word(s): Study
Allschwil, Switzerland, April 16, 2019
PRISM-UDR is a global Phase III multicenter, sponsor blinded, randomized, active-controlled, parallel-group, non-inferiority study of murepavadin combined with ertapenem in adult patients with nosocomial pneumonia due to Pseudomonas aeruginosa. The primary efficacy objective is to demonstrate non-inferiority (20% non-inferiority margin) of murepavadin compared to an anti-pseudomonal β-lactam-based antibiotic. The study was designed based on feedback from the U.S. Food and Drug Administration (FDA) and is agreed as the basis for a potential approval in the US. Eligible subjects with a high probability of nosocomial pneumonia due to Pseudomonas aeruginosa will be allocated at random to receive murepavadin or a comparator beta-lactam agent in a 1:1 ratio. The primary analysis population will comprise 210 subjects (105 subjects per arm) with nosocomial pneumonia confirmed to be due to Pseudomonas aeruginosa.
"The initiation of the PRISM-UDR clinical trial demonstrates our continued commitment to bringing forward this potential new treatment option for patients with nosocomial pneumonia due to Pseudomonas aeruginosa," commented Frank Weber, Polyphor Director and a.i. Chief Medical and Development Officer. "New therapeutic options are desperately needed, and we look forward to future clinical development milestones for murepavadin."
For more information about the PRISM-UDR clinical trial of murepavadin, please visit www.clinicaltrials.gov (Identifier: NCT03582007)
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