BiomX Cystic Fibrosis Trial Held by FDA

BiomX announced that the FDA has placed a hold on its cystic-fibrosis treatment trial. The announcement was made on Tuesday, not Monday as previously reported.

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on BiomX's cystic fibrosis treatment trial, BX004. The announcement was made on Tuesday, contrary to previous reports that indicated Monday as the date of the announcement [1][2].

BiomX, an Israel-based clinical-stage company, has been 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 Phase 2b trial of BX004 was paused due to the FDA's review of data on the third-party nebulizer used to deliver the drug. The FDA has not expressed any concerns about the drug itself, which has been cleared for clinical investigational use [3].

Patient screening and enrollment in the U.S. portion of the study have been paused, but enrollment and patient dosing outside of the U.S. continue to proceed. BiomX has submitted the requested data on the nebulizer device and believes the FDA's hold is temporary. The company remains optimistic that the FDA will lift the hold soon, allowing the trial to resume in the U.S. [3].

The clinical hold does not affect the ongoing study in Europe, where all components of the third-party nebulizer device are CE marked and have been deemed to meet applicable regulatory requirements. Enrollment and dosing of patients in Europe are continuing in accordance with the protocol [3].

BiomX remains committed to providing timely updates and full transparency to patients, physicians, and investors as the situation develops. The company expects to enroll up to approximately 60 patients in the Phase 2b trial of BX004 in CF patients with chronic P. aeruginosa lung infections once the FDA lifts the clinical hold.

References:

[1] https://www.morningstar.com/news/dow-jones/202508194603/fda-places-hold-on-biomx-cystic-fibrosis-treatment-trial
[2] https://www.marketwatch.com/story/fda-places-hold-on-biomx-cystic-fibrosis-treatment-trial-8beba77f
[3] https://www.theglobeandmail.com/investing/markets/markets-news/GlobeNewswire/34244572/biomx-provides-update-on-bx004-phase-2b-trial-for-the-treatment-of-patients-with-cystic-fibrosis/