27 March 2018
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 Gram-negative 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 30-40%. 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.
“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.”
Ignacio Martin-LoechesResearch Director of the Multidisciplinary Intensive Care Research Organization (MICRO) at Trinity College, Dublin, Ireland and Chairman of the Murepavadin PRISM program
“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,” “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.”
Dr. Debra BarkerChief Medical and Development Officer of Polyphor
About the PRISM-MDR study
PRISM-MDR is a Phase III multicenter, open label, randomised, active-controlled, parallel-group study focused on hospitals where multidrug resistant strains of Pseudomonas aeruginosa are frequent. The study will compare murepavadin combined with one other anti‑pseudomonal antibiotic against two other anti-pseudomonal antibiotics.
The study was designed based on feedback from the European Medicines Agency (EMA) and is agreed as the basis for a potential approval in the EU. The primary efficacy objective of the study is to assess the clinical cure rate at TOC in the mITT population. Eligible subjects with a high probability of VABP due to Pseudomonas aeruginosa will be randomized in a 2:1 ratio. The miTT population shall comprise 120 evaluable subjects (80 in the treatment arm) with VABP confirmed to be due to Pseudomonas aeruginosa.
About Murepavadin (POL7080)
Murepavadin is Polyphor’s most advanced product candidate and the first OMPTA in clinical development. It is being developed for the treatment of nosocomial pneumonia (including both hospital-acquired (HABP) and ventilator-associated bacterial pneumonia (VABP)) due to Pseudomonas aeruginosa and has been granted Qualified Infectious Disease Product (QIDP) and fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of VABP due to Pseudomonas aeruginosa.
Murepavadin is a pathogen specific antibiotic functioning through a novel mechanism of action involving binding to an outer membrane protein of Pseudomonas aeruginosa. In contrast to commonly used broad-spectrum antibiotics, murepavadin is a precision medicine and as such it supports the growing practice known as “antibiotic stewardship” which, among other things, seeks to reduce the excessive use of broad-spectrum products to avoid the buildup of resistance and to preserve the microbiome of the patients.
Based on promising Phase II results, Polyphor has agreed on a streamlined development pathway for murepavadin with the FDA and EMA and has started its first Phase III clinical trial.
Polyphor is a clinical stage, privately held Swiss specialty pharma company which has discovered and is developing the OMPTA (Outer Membrane Protein Targeting Antibiotics). The OMPTA are potentially the first new class of antibiotics against Gram-negative bacteria to have reached phase III stage in the last 50 years. The company’s lead product, murepavadin, (POL7080) is in Phase III development against Pseudomonas aeruginosa – recognized as a critical priority 1 pathogen by WHO. Polyphor is also developing an immuno-oncology candidate, balixafortide (POL6326), which has achieved clinical proof of concept in a Phase Ib/proof of concept study in combination with eribulin in patients with advanced breast cancer, and a pipeline of further preclinical antibiotics based on its OMPTA platform. Polyphor is based in Allschwil near Basel. For more information, please visit www.polyphor.com.
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