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NCT05327803 (Epetraborole in MAC Lung Disease): BVCT ex-ante prediction vs. reported outcome

On 24 Jul 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 8 Aug 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05327803
Drug Name
Epetraborole
Drug MoA
a novel bacterial leucyl-tRNA synthetase inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
MAC Lung Disease
Human Patients
314
Sponsor
AN2 Therapeutics
Phase
Phase 2 Phase 3

Prediction of , index 1695

Prospective Prediction
Prediction Index
1695
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in reinfection/relapse as an adjunctive therapy to SoC)
Technical Prediction
FAILURE (statistically insignificant additive clinical benefit in clinical response as an adjunctive therapy to SoC)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
15 days in advance
Readout Data Interpretation
13.9% placebo-adjusted difference (p=0.19) in PRO-based clinical response rate and trial discontinued for low efficacy.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official 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
Phase
Phase 2, Phase 3
Status
Terminated
Enrollment
177
Lead sponsor
AN2 Therapeutics, Inc
Conditions
MAC Lung Disease; Treatment Refractory MAC Lung Disease
Interventions
DRUG: Epetraborole; DRUG: Placebo
Design
Randomized · Parallel · Triple
Primary purpose
Treatment
Start
2022-05-20
Primary completion
2024-12-18
Completion
2024-12-18
Results first posted
2026-06-10
Primary outcomes
  • Phase 2: Adverse Event Profile of 500 mg Once Daily Dose of Epetraborole (Baseline to Month 16)
  • Phase 2: Percentage of Participants Achieving Clinical Response (Baseline to Month 6)
  • Phase 3: Percentage of Participants Achieving Clinical Response (Baseline to Month 6)

NCT05327803 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials