Allschwil, Switzerland, December 22, 2020
Polyphor receives approval to start first-in-human clinical trial of inhaled antibiotic murepavadin
- Phase I safety, tolerability, and pharmacokinetic study in healthy volunteers expected to start in coming weeks following acceptance of a request for a Clinical Trial Authorization (CTA) granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
- Polyphor’s inhaled murepavadin is a novel class antibiotic that specifically targets Pseudomonas aeruginosa lung infections in people with cystic fibrosis (CF).
- Phase I development in healthy volunteers is jointly funded by Polyphor and the European Innovative Medicines Initiative (IMI).
Polyphor AG (SIX: POLN) today announced that the UK Medicines and Healthcare products regulatory agency (MHRA) has granted a CTA (Clinical Trial Authorization) to start the first-in-human Phase I study of its novel class antibiotic murepavadin, delivered via the oral inhalation route.
The Phase I study is part of the clinical development plan exploring the inhaled formulation of murepavadin to treat Pseudomonas aeruginosa infections in people with cystic fibrosis, including resistant bacterial strains. The study is expected to enroll the first patient in the coming weeks. The safety, tolerability, and pharmacokinetic study is using eFlow(R) Technology nebulizer (PARI Pharma GmbH) to administer murepavadin Inhalation Solution (MIS) in healthy volunteers.
“We are very excited to further expand Polyphor’s clinical pipeline with the initiation of this study in a rare disease indication beyond our Phase III immuno-oncology program with balixafortide in advanced metastatic breast cancer. Patients with CF urgently need new antibiotic options against Pseudomonas aeruginosa infection which is the most important pathogen in progressive and severe CF lung disease”, said Dr. Frank Weber, Chief Medical and Development Officer at Polyphor. “Inhaled murepavadin has the potential to address this need and we would like to thank the European Innovative Medicines Initiative and the CF Foundation for their tremendous support and guidance in the development of this innovative program.”
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