AN2 Therapeutics Initiates P-III Part of a P-I/II Study to Evaluate Epetraborole for Treatment-Refractory MAC Lung Disease
- 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
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at firstname.lastname@example.org
Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at email@example.com.