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Epetraborole for Mycobacterium Avium Complex Lung Disease

Phase 2 & 3
Waitlist Available
Research Sponsored by AN2 Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cough with sputum production
Cough without sputum
Must not have
Patients with creatinine clearance (CrCl) of ≤30 mL/min, as estimated by the Cockcroft Gault formula, at Screening
Patients with hemoglobin <10.0 g/dL or <6.2 mmol/L at Screening; donation of blood or plasma within 28 days prior to randomization; or symptomatic loss of blood or hemorrhage within 28 days prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to month 16

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects of Epetraborole aren't listed here, common ones for new drugs can include nausea, diarrhea, liver issues like raised enzyme levels, potential heart rhythm problems (QT interval changes), allergic reactions or skin rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a cough that produces phlegm.
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I have a dry cough.
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I have chest congestion.
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I have been coughing up blood.
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I experience night sweats or unusual sweating.
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My MAC lung disease has not improved with treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function, measured by creatinine clearance, is 30 mL/min or less.
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My hemoglobin is above 10.0 g/dL, and I haven't donated blood or had significant blood loss recently.
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I have not had severe coughing up of blood recently.
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I do not have severe liver problems, such as very high liver enzyme levels or signs of advanced liver disease.
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I have a weak immune system that could lead to lung infections.
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I have never taken epetraborole before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to month 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 2: Adverse Event Profile of 500 mg Once Daily Dose of Epetraborole
Phase 2: Assessment of novel Patient Reported Outcome instrument psychometric properties
Phase 2: Percentage of Participants Achieving Clinical Response
+1 more
Secondary study objectives
14. Phase 2: Area Under the Plasma Concentration-Time Curve from Time Point 0 Hours Until 24 hours [AUC(0-24)] post dose
Phase 2: Change from Baseline in NTM Symptoms Module PRO
Phase 2: Change from Baseline in QOL-B Respiratory Domain PRO
+20 more

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epetraborole
2022
Completed Phase 1
~120

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Mycobacterium Avium Complex (MAC) Lung Disease include macrolides (azithromycin, clarithromycin), which inhibit bacterial protein synthesis by binding to the 50S ribosomal subunit, rifamycins (rifampin, rifabutin), which inhibit bacterial RNA synthesis by targeting RNA polymerase, and ethambutol, which disrupts cell wall formation by inhibiting arabinosyl transferases. These mechanisms are crucial for MAC Lung Disease patients as they target essential bacterial processes, reducing bacterial load and improving clinical outcomes. Epetraborole, a newer treatment under study, inhibits bacterial protein synthesis by targeting leucyl-tRNA synthetase, offering a novel mechanism that may be effective against treatment-refractory MAC infections, potentially addressing issues of drug resistance and treatment failure.

Find a Location

Who is running the clinical trial?

AN2 Therapeutics, IncLead Sponsor
4 Previous Clinical Trials
315 Total Patients Enrolled

Media Library

Epetraborole (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05327803 — Phase 2 & 3
Mycobacterium Avium Complex Lung Disease Research Study Groups: epetraborole + OBR, placebo + OBR
Mycobacterium Avium Complex Lung Disease Clinical Trial 2023: Epetraborole Highlights & Side Effects. Trial Name: NCT05327803 — Phase 2 & 3
Epetraborole (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05327803 — Phase 2 & 3
~10 spots leftby Dec 2024