Epetraborole for Mycobacterium Avium Complex Lung Disease

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: AN2 Therapeutics, Inc

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called epetraborole, given with standard treatments, in adults with hard-to-treat MAC lung disease. The goal is to see if epetraborole can help clear the lung infection when other treatments have failed.

Eligibility Criteria

Adults with treatment-refractory MAC lung disease, who have persistent symptoms like coughing and fatigue despite previous treatments. They must show signs of the disease on a CT scan and have positive sputum samples for MAC. Participants should be able to survive with ongoing care, agree to birth control use, and commit to study requirements.

Inclusion Criteria

I have a cough that produces phlegm.

I have a dry cough.

I have chest congestion.

I have been coughing up blood.

I experience night sweats or unusual sweating.

My MAC lung disease has not improved with treatment.

Exclusion Criteria

My kidney function, measured by creatinine clearance, is 30 mL/min or less.

My hemoglobin is above 10.0 g/dL, and I haven't donated blood or had significant blood loss recently.

I have not had severe coughing up of blood recently.

I do not have severe liver problems, such as very high liver enzyme levels or signs of advanced liver disease.

I have a weak immune system that could lead to lung infections.

I have never taken epetraborole before.

Treatment Details

The trial is testing Epetraborole added to an optimized background regimen (OBR) against a placebo plus OBR in patients whose MAC lung disease hasn't improved with standard treatment. It's a critical Phase 2/3 study where participants are randomly assigned to either the drug or placebo group.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: epetraborole + OBRExperimental Treatment1 Intervention

epetraborole + Optimized Background Regimen

Group II: placebo + OBRPlacebo Group1 Intervention

Placebo + Optimized Background Regimen