RHB-204 for the Treatment of Pulmonary Mycobacterium Avium Complex Disease

Key Inclusion Criteria * Males and females aged ≥18 years to ≤85 years of age, inclusively * Have a MAC lung infection documented by one MAC positive culture within 18 months prior to screening and a MAC positive culture at screening (cultures need to be at least 1 month apart). Prior sputum for culture may be obtained from sputum or bronchial washings however, sputum collected during screening must be either spontaneously expectorated by the patient or after sputum induction. * Have MAC lung infection with evidence of underlying nodular infiltrates and/or bronchiectasis on a chest computed tomography (Chest CT) within 6 months of screening. * Have symptoms of MAC lung infection that include one of the following: respiratory symptoms such as chronic cough, excessive mucous production, fatigue, dyspnea, hemoptysis or systemic symptoms such as fever, night sweats or loss of appetite. * Be treatment naïve, or if previously treated for MAC, have not received treatment within the 6 months prior to screening * Subject's weight is above 41 Kilograms or 90 pounds. Key Exclusion Criteria * Cavitary lung disease as observed on a chest CT scan (cavitary lesions exceeding 2 cm in diameter). * Currently taking or treated in the 6 months prior to screening with any of the following: bedaquiline, clofazimine or any component of American Thoracic Society(ATS)/Infectious Diseases Society of America (IDSA) multi-drug recommended therapy (macrolides, ethambutol, rifabutins/rifampins) for MAC…