BiomX Says FDA Places Clinical Hold On Phase 2b Trial Of BX004 For Treatment Of Patients With Cystic Fibrosis

Author: Benzinga Newsdesk | August 19, 2025 07:21am

U.S. FDA has placed a clinical hold on the Phase 2b study as it reviews data submitted by BiomX on third-party nebulizer used to deliver BX004; no concerns were raised in the clinical hold notification regarding the BX004 drug candidate

Enrollment and dosing of patients outside the US is continuing in accordance with protocol

NESS ZIONA, Israel, Aug. 19, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE:PHGE) ("BiomX" or the "Company"), a clinical-stage company advancing novel natural and engineered phage therapies targeting specific pathogenic bacteria, today 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.

Posted In: PHGE