Spero Therapeutics Reports Phase 1 Results Show Significant Lung Uptake Of SPR719

(RTTNews) - Spero Therapeutics Inc. (SPRO) announced that phase 1 results indicated significant lung uptake of SPR719, with enhanced concentrations in epithelial lining fluid (ELF) and alveolar macrophages (AM). This is attributed to the fact that unbound plasma concentrations primarily influence penetration into lung compartments.

The study was designed to determine safety and intrapulmonary PK of SPR719, including concentrations in pulmonary epithelial lining fluid (ELF) and alveolar macrophages (AM) in the lung to provide essential dose selection information for the development of SPR720 for the treatment of Non Tuberculous Mycobacterial- Pulmonary Disease (NTM-PD).

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 (BAL) 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.

The 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, the company said.

The company noted that the results from the study of the intrapulmonary disposition of SPR719 support further investigation of SPR720 as a potential oral agent for treatment of NTM-PD.

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