BiomX announces U.S. FDA placed clinical hold on Phase 2b trial of BX004

BiomX (PHGE) announced that the U.S. Food and Drug Administration, FDA, has placed a clinical hold on the Phase 2b trial of BX004 for the treatment of patients with cystic fibrosis, CF. In its notification, the FDA solely focused on the third-party nebulizer device utilized to deliver BX004. The BX004 drug product candidate has already been reviewed by the FDA and has been cleared for clinical investigational use with no concerns indicated to BiomX. Following the FDA’s hold notification, which the company believes to be temporary, BiomX promptly submitted the additional requested data which was generated independently by the well-established manufacturer of the nebulizer device, and this data is expected to provide the information required by the FDA to lift the hold. As a result of the FDA’s notification, patient screening and enrollment in the U.S. portion of the Phase 2b trial of BX004 have now been paused. In Europe, all components of the third-party nebulizer device are CE marked and thus have been deemed to meet applicable regulatory requirements. The study in the EU has been approved and enrollment and dosing of patients is continuing in accordance with the protocol.