According to Polyphor, the UK’s MHRA has authorized a Phase 1 study of the company’s murepavadin inhalation solution, which the company is developing for the treatment of Pseudomonas aeruginosa lung infections in cystic fibrosis patients. Initiation of the study, which is partially funded by the European Innovative Medicines Initiative, is expected within weeks. The company also said that it expects to initiate a Phase 1b/2a trial in adult CF patients following completion of the Phase 1 study, with funding for that trial provided by the Cystic Fibrosis Foundation.
The Phase 1 SAD/MAD study will evaluate murepavadin in healthy volunteers who will receive the inhalation solution via the PARI eFlow nebulizer. Polyphor says that preclinical studies have demonstrated that the the safety profile of inhaled murepavadin is at least 5-10 times higher than intravenous murepavadin.
Polyphor Chief Medical and Development Officer Frank Weber said, “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 3 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. 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.”
Read the Polyphor press release.
