Spero Therapeutics announces publication of SPR719 trial data

Spero Therapeutics announced the publication of data from its Phase 1 clinical trial, which assessed the intrapulmonary pharmacokinetics, or PK, of SPR719. The full manuscript was published ahead of print in Antimicrobial Agents and Chemotherapy. This was a Phase 1, single-center, open-label study in healthy adult male and female subjects. Subjects received a 1,000 mg dose of SPR720 administered once daily for 7 days. Blood samples were collected for plasma pharmacokinetic assessments. Each subject also underwent a standardized bronchoscopy and Bronchoalveolar Lavage on Day 7. The safety population comprised 33 healthy adult subjects, and the PK population included 30 subjects. There were no meaningful concentrations of SPR720 detected in the plasma. Mean plasma concentrations of SPR719 reached a peak at approximately 4 hours and then declined over the remaining 24 hours. The concentrations of SPR719 in ELF and AM were found to be greater than total plasma concentrations. These results suggested that SPR719 had significant lung uptake and enhanced ELF and AM concentrations because unbound plasma concentrations predominantly influence penetration into lung compartments. No unexpected safety findings were observed. Results from this study of the intrapulmonary disposition of SPR719 support further investigation of SPR720 as a potential oral agent for treatment of NTM-PD.