Approval Probability
TA Base Rate
Adjusted LOA
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BX004 · 1 trial · 2 indications
Change from baseline in PsA colony-forming units (CFU) per g of sputum
| Arm | Type | Description |
|---|---|---|
| BX004 | EXPERIMENTAL | Participants will be randomized to receive standard dose of nebulized bacteriophage |
| Placebo | PLACEBO_COMPARATOR | Participants will be randomized to receive nebulized placebo |
| Name | Type | Description |
|---|---|---|
| BX004 | BIOLOGICAL | Bacteriophage |
| Placebo | OTHER | Placebo |
Key Inclusion Criteria: * Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care inhaled antibiotics (cycling or continuous regimen) or no inhaled antibiotics * Age ≥ 18 years * FEV1 40%-80% predicted * Clinically stable lung disease * Willing an...
BX004 is an investigational therapy being developed for chronic Pseudomonas aeruginosa infection in people with cystic fibrosis. It is designed to target Pseudomonas bacteria in the lungs of CF patients. BX004 is currently in Phase 2 clinical development and has not been approved by the FDA.
BX004 is being developed by BiomX Inc., a biotechnology company whose common stock trades on the NYSE American under the ticker symbol PHGE. BiomX is the sponsor of the clinical program evaluating BX004 in patients with cystic fibrosis and chronic Pseudomonas aeruginosa lung infection.
BX004 is in Phase 2 clinical development. The ongoing trial is a Phase 2 study that is currently recruiting participants. BX004 has not completed any clinical trials and has not received FDA approval for any indication.
BX004 is being evaluated in a single Phase 2 clinical trial, NCT06998043, titled Study With Phage for CF Subjects With Pseudomonas Lung Infection. The trial is recruiting in the United States, has an estimated enrollment of 63 adults aged 18 and older, and is randomized, double-blind, and placebo-controlled.
BX004 has received Orphan Drug designation from the FDA for its development in chronic Pseudomonas aeruginosa infection. This designation is granted to investigational therapies intended to treat rare diseases or conditions. BX004 remains investigational and has not been approved by the FDA.