A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of SPR720 as Compared With Placebo for the Treatment of Participants With Mycobacterium Avium Complex (MAC) Pulmonary Disease
Summary
The purpose of the study is to evaluate 1. The microbiological response and clinical efficacy of SPR720 compared with placebo in participants with nontuberculous mycobacteria pulmonary disease (NTM-PD). 2. The safety and tolerability of SPR720 in participants with NTM- PD 3. The pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in participants with NTM-PD.
Timeline
- Start
- 2022-12-14
- Primary completion
- 2024-10-08
- Completion
- 2024-12-02
Outcome
Missed primary endpoint
paper For the primary efficacy endpoints, observed weekly sputum log10 CFU/mL and time to positivity, no difference was observed among treatment groups PMID 41720869 ↗
release “Phase 2a proof-of-concept study of SPR720 for the treatment of Nontuberculous Mycobacterial Pulmonary Disease (NTM-PD) did not meet its primary endpoint” sperotx.com ↗