Epetraborole for Mycobacterium Abscessus Infection
(REBOUND Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called epetraborole for individuals with lung disease caused by Mycobacterium abscessus. The study aims to evaluate the drug's effectiveness when taken daily at different doses compared to a placebo (a harmless pill resembling the real drug). Suitable participants have Mycobacterium abscessus lung disease, experience symptoms like chest pain or cough, and have shown the bacteria in recent tests. The goal is to determine if epetraborole can improve symptoms and reduce bacterial presence. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients with certain infections or on specific treatments must complete those treatments before joining. It's best to discuss your current medications with the trial investigator.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that epetraborole has undergone testing in several studies to assess its safety. In these studies, participants received either single or multiple doses. Researchers carefully monitored the safety of epetraborole using standard medical checks and lab tests.
In earlier research, patients received epetraborole either through an IV (a method where the drug is given directly into the vein) or by mouth. These studies suggested that most participants tolerated the treatment well. No major safety issues emerged, and any side effects were usually mild. Common side effects, if they occurred, were similar to those from other medications, such as mild stomach upset or headaches.
This current trial is in the middle phase of testing, which helps gather more information about the drug's safety and tolerability in a larger group of people. So far, evidence suggests that epetraborole is safe for further testing in patients with Mycobacterium abscessus lung infections.12345Why are researchers excited about this study treatment for Mycobacterium abscessus?
Most treatments for Mycobacterium abscessus infections involve combinations of antibiotics like azithromycin, amikacin, and imipenem, which can be tough on the body and lead to antibiotic resistance. But Epetraborole works differently, targeting an essential enzyme in the bacteria that current treatments don't. This unique mechanism gives it the potential to be effective even against resistant strains. Researchers are excited about Epetraborole because it may offer a more targeted approach, potentially improving outcomes and reducing side effects compared to standard therapies.
What evidence suggests that this trial's treatments could be effective for Mycobacterium abscessus lung disease?
Research suggests that epetraborole could be effective against Mycobacterium abscessus, a type of lung infection. In lab studies, epetraborole demonstrated strong effects against this bacteria, with effective amounts ranging from 0.03 to 0.25 mg/L. Animal studies also support its potential, showing a significant decrease in lung bacteria when treated with epetraborole. Although no data from human studies exists yet for this specific lung disease, the lab and animal research indicate it might be a helpful treatment. Participants in this trial will receive either a high or low dose of epetraborole, or a matching placebo, to further evaluate its effectiveness in humans.12467
Who Is on the Research Team?
Kevin L Winthrop, MD, MPH
Principal Investigator
Oregon Health and Science University
Are You a Good Fit for This Trial?
Adults with mild to moderate Mycobacterium abscessus lung disease can join this trial. Participants must meet certain health standards based on previous phases of the drug's testing and standard care procedures. They should not have conditions that could increase risks or affect study results.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 500 mg or 750 mg of Epetraborole or placebo daily for 84 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Epetraborole
Trial Overview
The trial is testing Epetraborole (EBO) at two different doses, 500 mg and 750 mg daily, against a placebo for treating Mycobacterium abscessus lung disease. It's double-blind and randomized, meaning neither doctors nor patients know who gets the real drug or placebo.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
This arm is a daily treatment regimen of a 500mg oral dose of Epetraborole.
This arm is a daily treatment regimen of a 750mg oral dose of Epetraborole.
This arm is a daily treatment regimen of a placebo, matching the high dose experimental arm.
This arm is a daily treatment regimen of a placebo, matching the low dose experimental arm.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kevin Winthrop
Lead Sponsor
AN2 Therapeutics, Inc
Industry Sponsor
Citations
Efficacy of epetraborole against Mycobacterium abscessus ...
Our results emphasize the effectiveness of EPT against the clinically relevant cystic fibrosis pathogen M. abscessus, and these findings also suggest norvaline ...
Efficacy of epetraborole against Mycobacteroides abscessus ...
While 50 mg/kg EBO produced a larger reduction in lung CFU burden at the end of 2 weeks of treatment, 25 mg/kg and 50 mg/kg EBO produced ...
Epetraborole in Patients With Mycobacterium Abscessus ...
To date, no clinical efficacy data are available for use of EBO in humans with MABc-LD. However, available nonclinical and PK data support the ...
Epetraborole, a Potential Oral Agent for Mycobacterium ...
Efficacy of epetraborole against Mycobacteroides abscessus in a mouse model of lung infection. Rimal et al. AAC 2024 68:e0064824. 7. Potency of omadacycline ...
In vitro susceptibility of 147 international clinical ...
Epetraborole demonstrated potent in vitro activity against M. abscessus with MICs from 0.03 to 0.25 mg/L and consistent activity against all subspecies.
Pharmacokinetic-Pharmacodynamic Target Attainment ...
Safety data gathered from five Phase 1 and two Phase 2 studies in which subjects or patients received single or multiple intravenous (IV) or ...
Epetraborole plus norvaline for M. abscessus
abscessus lung infection with norvaline supplementation. Rifabutin (RFB) acts as positive control. Data shown is mean ± SD of three to five mice.
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