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Polyphor announces enrollment of first patient in Phase III clinical trial for murepavadin – a pathogen-specific antibiotic being developed for the treatment of nosocomial pneumonia

Potentially first new class of antibiotics in Phase III development against Gramnegative pathogens in 50 years
Polyphor today announced the enrollment of the first patient in its PRISM-MDR European Phase III clinical trial for murepavadin (POL7080) for the treatment of ventilator-associated bacterial pneumonia (VABP) due to Pseudomonas aeruginosa.
Among the Gram-negative bacteria, Pseudomonas aeruginosa is one of the most dangerous bacteria. It is responsible for approximately 10% of all hospital-acquired infections and the second-leading cause of nosocomial pneumonia, with mortality rates of approximately 3040%. Its strain that is resistant against the widely used antibiotic carbapenem has been classified as one of the top three critical pathogens by the World Health Organization (WHO).
Murepavadin is the lead compound in Polyphor’s new class of antibiotics, the Outer Membrane Protein Targeting Antibiotics (OMPTA), which are potentially the first new class of antibiotics against Gram-negative bacteria to reach Phase III clinical development in more than 50 years. In contrast to commonly used broad-spectrum antibiotics, murepavadin is a pathogen specific antibiotic with a novel mechanism of action against which pathogens may only slowly build resistance.
Ignacio Martin-Loeches, Research Director of the Multidisciplinary Intensive Care Research Organization (MICRO) at Trinity College, Dublin, Ireland and Chairman of the Murepavadin
PRISM program commented, “The treatment of HABP/VABP caused by Pseudomonas aeruginosa is becoming more challenging and new therapeutic options are desperately needed. The very potent and extensive coverage of murepavadin positions it well where there are risk factors associated with Multi Drug Resistant Pseudomonas aeruginosa nosocomial pneumonia as well as in stewardship programs where the de-escalation of broad spectrum agents is warranted after availability of susceptibility data.”
“We believe murepavadin may lead to a paradigm shift in the treatment of nosocomial pneumonia due to Pseudomonas aeruginosa and become the standard of care in the treatment of patients with confirmed nosocomial pneumonia due to multidrug resistant and extensively drug-resistant strains,” said Dr. Debra Barker, Chief Medical and Development Officer of Polyphor. “Our Phase II study showed promising results and, following discussions with both the FDA and EMA, we have agreed a streamlined development pathway towards completion of Phase III clinical development for murepavadin. The enrollment of the first patient in our European trial is a significant step towards bringing forward this new treatment option.”