Drug intelligence / Profile preview

BX004

Development stage
Phase 2
Lead developer
BiomX, Inc.
Modality
Live Biotherapeutic Products → Microbiome Therapeutics
Administration
Inhalation
01

Overview

BX004 is BiomX's investigational, nebulized fixed three-bacteriophage cocktail for chronic pulmonary *Pseudomonas aeruginosa* infection in people with cystic fibrosis. The phages are intended to selectively infect, replicate within, and lyse susceptible *P. aeruginosa* cells, thereby lowering bacterial burden in the airways. BX004-A was evaluated in a Phase 1b/2a study, and BiomX subsequently initiated a Phase 2b study; however, BiomX discontinued the Phase 2b cystic-fibrosis trial on December 8, 2025, following Data Monitoring Committee feedback and an internal review of unexpectedly high adverse-event rates. ([nature.com](https://www.nature.com/articles/s41467-025-60598-4))

02

Targets

P. aeruginosa LPS (Pseudomonas aeruginosa lipopolysaccharide)BtuB (Vitamin B12 transporter BtuB)OprM (Outer membrane protein OprM)P. aeruginosa (Pseudomonas aeruginosa)

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