MHRA approves Polyphor’s phase 1 trial of novel inhaled antibiotic

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Swiss biotech Polyphor’s first-in-human phase I study of its novel inhaled antibiotic murepavadin.

Murepavadin is in development as a precision antibiotic to treat chronic Pseudomonas aeruginosa infections in people with cystic fibrosis (CF).

It is an outer membrane protein targeting antibiotic (OMPTA) – a novel class of antibiotics discovered by Polyphor and the University of Zurich.

The phase I study will evaluate the safety and tolerability of single and multiple ascending doses of inhaled murepavadin in healthy volunteers and will be jointly funded by Polyphor and the European Innovative Medicines Initiative (IMI).

The early-stage trial is part of Polyphor’s clinical development programme, which is aiming to explore the inhaled formulation of murepavadin to treat Pseudomonas aeruginosa infections in people with cystic fibrosis, including resistant bacterial strains.

The company is expecting to enrol the first patient into the phase I study in the coming weeks, with a phase Ib/IIa trial in adults with CF planned to launch following completion of the first study in 2021.

Polyphor also recently received an award from the Cystic Fibrosis Foundation which will allow for further development of murepavadin until the end of the phase Ib/IIa study.

"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 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 programme."