FDA Places Clinical Hold on BiomX's Phase 2b BX004 Study

The FDA has placed a clinical hold on BiomX's Phase 2b study for BX004 due to concerns about the third-party nebulizer used to deliver the drug. Enrollment and dosing outside the US is continuing as planned. The FDA has reviewed BX004 and cleared it for clinical use with no concerns. BiomX is working with the FDA to resolve the clinical hold.

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on BiomX Inc.'s (NYSE American: PHGE) Phase 2b trial of BX004, a cystic fibrosis treatment. The hold is specific to the third-party nebulizer device used for drug delivery, with no issues raised regarding the BX004 drug candidate itself [1].

BiomX announced the FDA's decision on August 19, 2025, stating that the hold concerns the nebulizer device used to deliver BX004. The company has already submitted additional data from the nebulizer manufacturer to the FDA and expects this information to resolve the hold. While U.S. patient screening and enrollment are temporarily paused, the European trial continues unaffected as the nebulizer components are CE marked and meet EU regulatory requirements [1].

Jonathan Solomon, Chief Executive Officer of BiomX, said, "We are actively engaged with the FDA to promptly address their queries regarding the third-party nebulizer. Importantly, the FDA’s notification relates solely to the nebulizer, and we remain optimistic and confident that in response to the hold, we have provided the FDA with data that can satisfactorily support the use of the nebulizer and that this can be resolved promptly so that we may resume treating patients with cystic fibrosis in the U.S." [1].

About BX004
BiomX is developing BX004, a fixed multi-phage cocktail, for the treatment of cystic fibrosis (CF) patients with chronic pulmonary infections caused by Pseudomonas aeruginosa (P. aeruginosa). The company has already announced positive results from Phase 1b/2a studies, showing safety, tolerability, and microbiologic activity [1].

References
[1] https://www.stocktitan.net/news/PHGE/biom-x-provides-update-on-bx004-phase-2b-trial-for-the-treatment-of-t0vv0qwcv6fk.html