A study to evaluate the effects of ALIS based treatment in patients newly diagnosed with nontuberculous mycobacterial lung infection caused by MAC

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• Subjects who meet any of the following criteria will be disqualified from entering the study: 1. Diagnosis of CF. 2. History of more than 3 MAC lung infections (a 4th MAC lung infection is not eligible). 3. Received any mycobacterial antibiotic treatment for current MAC lung infection 4. Refractory MAC lung infection, defined as having positive MAC cultures while being treated with a multidrug mycobacterial antibiotic treatment regimen for a minimum of 6 consecutive months and no documented successful treatment, defined as negative sputum culture for MAC and cessation of treatment. 5. Relapse of prior MAC lung infection, defined as positive sputum culture for MAC ≤6 months of cessation of prior successful treatment 6. MAC isolate with MIC for amikacin ≥ 128 μg/mL at Screening. 7. Evidence of any pulmonary cavity ≥ 2 cm in diameter, as determined by chest CT scan, read locally, during Screening or within 6 months prior to Screening. 8. Radiographic finding of new lobar consolidation, atelectasis, significant pleural effusion, or pneumothorax during routine clinical care within 2 months prior to Screening. 9. Active pulmonary malignancy (primary or metastatic) or any malignancy requiring chemotherapy or radiation therapy within 1 year prior to Screening or anticipated during the study. 10. Active pulmonary tuberculosis requiring treatment during Screening. 11. Hospitalization for underlying lung disease during Screening. 12. Acute pulmonary exacerbation (eg, COPD or bronchiectasis) requiring treatment with antibiotics, or corticosteroids (IV or oral), within 4 weeks prior to and during Screening. 13. Forced expiratory volume in 1 second (FEV1) < 35% of predicted, pre-bronchodilator use. 14. Current smoker. 15. History of lung transplantation. 16. Use of inhaled or systemic aminoglycosides with activity against MAC (eg, amikacin, kanamycin, or streptomycin) during Screening.
• 17. Prior exposure to ALIS (including clinical study). 18. Known hypersensitivity or contraindications to use to ALIS, aminoglycosides, or any of their excipients. 19. Disseminated MAC infection. 20. Positive pregnancy test or lactation at Screening. All WOCBP will be tested. Women not of childbearing potential are defined as postmenopausal (ie, amenorrheic for 12 months without an alternative medical cause or confirmed by more than one follicle stimulating hormone [FSH] measurement), or naturally or surgically sterile through bilateral oophorectomy, hysterectomy, or bilateral salpingectomy. For women under the age of 45 years, confirmatory testing with FSH should be considered. 21. Administration of any investigational drug within 8 weeks prior to Screening. 22. Known or suspected acquired immunodeficiency syndromes (HIVpositive, regardless of CD4 counts). Other immunodeficiency syndromes that may interfere with study participation in the opinion of the Investigator. 23. Significant (as determined by the Investigator) hearing loss, vestibular dysfunction, neuromuscular weakness or a diagnosis of myasthenia gravis, where the potential risk of aminoglycoside toxicity outweighs the potential benefit. 24. Aspartate aminotransferase or alanine aminotransferase ≥ 3 times the upper limit of normal (ULN) or total bilirubin ≥ 1.5 times ULN at Screening. 25. Absolute neutrophil count ≤ 500/μL at Screening. 26. Serum creatinine > 2 times ULN at Screening. 27. Current alcohol, medication, or illicit drug abuse. 28. Any condition that, in the opinion of the Investigator, interferes with ability to safely complete the study or adhere to study requirements. 29. Known and active COVID-19 infection. 30. MAC isolate with MIC for clarithromycin ≥ 32 μg/mL at Screening. 31. Known hypersensitivity or contraindications to use of ethambutol, azithromycin (including other macrolides or ketolides), or any of their excipients per local labeling guidance.