Spexis (formerly Polyphor) said that a Phase 1 study of inhaled murepavadin, which the company is developing for the treatment of P. aeruginosa lung infections, demonstrated that the inhaled formulation delivered via the PARI eFlow nebulizer was well tolerated at all dose levels and that concentrations of murepavadin in the lungs reached the desired levels while plasma levels remained low. Polyphor announced the initiation of the Phase 1 study in December 2021.
The SAD study enrolled a total of 39 subjects and evaluated single doses at 12.5 mg, 25mg, and 50 mg dose levels in the first part and single doses of 75 mg, 150 mg, and 300 mg inhaled murepavadin in the second part. Murepavadin concentrations were measured in the blood as well as in epithelial lining fluid.
According to Spexis, at the 300 mg dose, murepavadin levels in the epithelial lining fluid remained at a level greater than that needed to inhibit 90% of P. aeruginosa growth at 24 hours post dose. Peak plasma concentrations occurred at 1 to 2 hours after the initiation of dosing with systemic biovailability at less than 5%. The company said that no serious adverse events were reported, and all pulmonary function tests conducted after dosing were normal.
Spexis Chief Medical Officer Juergen Froehlich commented, “The first clinical data with our inhaled murepavadin hold promise as we work to bring more efficacious and safe treatments for serious lung infections to patients in need, including people with cystic fibrosis and non-CF bronchiectasis. The strong collaboration established between Spexis and the European Innovative Medicines Initiative was an enabler for us to conduct this important first-in-human trial, and we are grateful for the IMI’s ongoing support. We look forward to continuing to advance this product candidate in clinical development.”
Read the Spexis press release.
