Studies

MKC-CI-002, MNKD-101, Pulmonary Nontuberculous

Internal Medicine Pulmonology Lung Disease Adult Subjects

This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT)

SPR720-202, SPR720, for MAC Pulmonary Disease

Internal Medicine Pulmonology Lung Disease Adult Subjects

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 a participants population with NTM- PD
3. The pharmacokinetic (PK) of SPR719, active moiety, following orally (po) administered prodrug SPR720 in a participant population with NTM-PD.

EBO-301, Epetraborole for MAC lung disease

Internal Medicine Pulmonology Lung Disease Adult Subjects

This is a pivotal Phase 2/3, double-blind, placebo-controlled study of epetraborole + OBR (Optimized Background Regimen) versus placebo + OBR in patients with treatment-refractory MAC lung disease. This study will enroll adult patients with treatment-refractory MAC lung disease who meet all eligibility criteria (including clinical, radiographic, and microbiological criteria).

ENCORE INS-416 Amikacin MAC Study

Internal Medicine Pulmonology Lung Disease Adult Subjects

The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin \[AZI\] + ethambutol \[ETH\]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.