Polyphor and EnBiotix have announced the initiation of Phase 1 trial of nebulized murepavadin in healthy volunteers; Polyphor had announced approval of a Phase 1 study by the MHRA in December 2020. The murepavadin inhalation solution, which is delivered via the PARI eFlow nebulizer, is in development for the treatment of P. aeruginosa lung infections in cystic fibrosis patients.
The Phase 1 study is being sponsored by Polyphor, even though the company recently sold all assets related to inhaled murepavadin to EnBiotix, and the study is being funded by Polyphor and the European Innovative Medicines Initiative (IMI). A planned Phase 1b/2a study expected to follow will be funded by a grant from the Cystic Fibrosis Foundation, the companies said.
Polyphor plans to merge with EnBiotix, which is developing several other inhaled antibiotics, including tobramycin for CF infections, amikacin for non-tuberculous mycobacteria (NTM) infections, and ColiFin colistimethate sodium for CF, non-CF bronchiectasis, and COPD. EnBiotix has licensed the rights to market ColiFin outside of Europe from PARI.
EnBiotix Chairman and CEO Jeffrey Wager commented, “We are very excited about the start of this important trial with inhaled murepavadin in a rare pulmonary disease indication. Even with the advent of CFTR corrector therapy, CF patients with chronic Pseudomonas aeruginosa infection still urgently need new antibiotic options and inhaled murepavadin has the potential to provide a significant advancement in the treatment of these patients. As we progress to complete the planned merger with Polyphor this year, we ensure timely continuation of our programs, and we are grateful to the European Innovative Medicines Initiative (IMI) for their tremendous support and guidance.”
Read the Polyphor and EnBiotix press release.
