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AN2 EBO301 MAC Study

Title A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter, Prospective Study to Assess the Efficacy, Safety, and Pharmacokinetics of Orally Administered Epetraborole in Patients with Treatment-refractory Mycobacterium avium Complex Lung Disease (MACrO2)
Therapeutic Area Mycobacterial Disease
Principal Investigator Yoav Golan, MD
Min Age 18 Years
Gender Any
Contact Olaniyi Ogunbodede
More Information


This study is being conducted in patients with refractory Mycobacterium Avium Complex (MAC), a serious condition which can cause damage to your lung, and is resistant to other treatments. The study is looking at how effective the study drug, Epetraborole in the treatment of refractory MAC. Epetrabole is a oral pill to be taken as 2 tablets one time daily by mouth. Details of study visits are explained below.

Study Details

Inclusion Criteria

1.Must be 18 years or older, willing and able to provide written informed consent.

2. Must have been diagnosed with refractory MAC lung disease.

3. Must be willing to comply with all the study activities and procedures throughout the duration of the study.

Exclusion Criteria

1.Patient with active lung cancer or any cancer that would required chemotherapy or radiation therapy within 1 year prior to enrollment.

2. Patient wth an immunocompromised condition and risk of having lung infection

3. Patient with any prior exposure to Eprtraborole

Study Requirements

If you agree to join, you will be in the study for approximately 8 weeks from screening up to 19 months, which include monthly study visit to the study site. You will be randomly assigned (like tossing a coin) to receive either the study drug or placebo (inactive drug). You will need to take 2 tablets of study medicine by mouth (Epetraborole or placebo) once a day, until you are directed to stop by your study doctor. During the study, you will have tests done at several times, including chest CT Scan, as well as having blood drawn. You may be enrolled in the phase 2 or phase 3 portion of the study. The total number of study visits and volume of blood collected will depend on the phase of the study you are enrolled in.