Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 monoclonal antibody being developed for chronic Pseudomonas aeruginosa infection, specifically in patients with cystic fibrosis (CF). It is currently in Phase 2 clinical development and has not been approved by the FDA.
BX004 is a monoclonal antibody designed to target Pseudomonas aeruginosa, the bacteria responsible for chronic lung infections in cystic fibrosis patients. By binding to the bacteria, it aims to help the immune system clear the infection, though the specific molecular target has not been disclosed.
BX004 is being developed by BiomX Inc., a biopharmaceutical company. BiomX is publicly traded under the ticker symbol PHGE on the stock exchange.
BX004 is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The drug has been granted Orphan Drug and Fast Track designations by the FDA.
BX004 is being evaluated in a Phase 2 clinical trial with the identifier NCT06998043. This is a randomized, double-blind, placebo-controlled study enrolling 63 participants with chronic Pseudomonas aeruginosa infection and cystic fibrosis. The trial is currently recruiting in the United States.
No, BX004 is a monoclonal antibody, not a phage therapy. Although the clinical trial title mentions 'phage,' the drug itself is a monoclonal antibody designed to treat Pseudomonas aeruginosa infections in cystic fibrosis patients.