FDA Places Clinical Hold on BiomX US Cystic Fibrosis Trial, Europe Continues

The U.S. Food and Drug Administration has placed a clinical hold on BiomX's Phase 2b trial of BX004, a cystic fibrosis treatment, due to concerns about the third-party nebulizer device used for drug delivery. The hold affects patient screening and enrollment only in the U.S., while dosing and enrollment continue in Europe where the nebulizer components meet regulatory standards. BiomX has clarified that the FDA has not raised any concerns regarding the BX004 drug itself, which has already been cleared for clinical investigational use. The company has submitted additional data from the nebulizer manufacturer to address the FDA's queries and expects the hold to be temporary. CEO Jonathan Solomon expressed confidence in resolving the issue and resuming the U.S. trial soon. The Phase 2b trial aims to evaluate BX004's impact on lung function, bacterial load, and quality of life in cystic fibrosis patients.