AN2 Therapeutics Initiates P-III Part of a P-I/II Study to Evaluate Epetraborole for Treatment-Refractory MAC Lung Disease
Shots:
- The P-III part of the clinical trial evaluating if epetraborole (QD, oral) + OBR, consisting of two or more SoC drugs, is superior to PBO + OBR for patients (n≈ 234) with treatment-refractory MAC lung disease which is expected to support regulatory filings for approval in the US and Japan
- Earlier, it received FTD and QIPD for the same indication, and ODD for the treatment of infections caused by NTM
- The P-II part of the trial (n=80) evaluates clinical response using various patient-reported outcome tools as well as the safety, efficacy, and PK of epetraborole + optimized background regimen (OBR) vs. PBO + OBR. The P-II results will be used for clinical response measures and the final sample size in the P-III part of the trial. P-II topline data is expected to be released in 2024
Ref: Businesswire | Image: AN2 Therapeutics
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