According to BiomX, the FDA has placed a clinical hold on the company’s recently-initiated Phase 2b trial of BX004 inhaled phage cocktail in cystic fibrosis patients with chronic P. aeruginosa lung infections. BiomX said that the FDA notification requested additional data related to the nebulizer used to deliver BX004 and that those data have now been submitted to the agency. The study is moving ahead in Europe, the company says, while the US sites have paused screening and enrollment.
In November 2023, BiomX announced positive results from the second part of a Phase 1b/2a trial. Earlier this year, the company announced that it had raised sufficient funds to allow the Phase 2b trial to move ahead.
BiomX CEO Jonathan Solomon commented, “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 BiomX remains committed to providing timely updates and full transparency to patients, physicians, and investors as the situation develops.”
Read the BiomX press release
