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Also known as Bacteriophage
BX004-A · 1 trial · 2 indications
Incidence of treatment emergent adverse events following single and multiple doses of BX004-A administered by inhalation
| Arm | Type | Description |
|---|---|---|
| BX004-A | 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-A | DRUG | Combination of nebulized bacteriophages targeting Pseudomonas aeruginosa |
| Placebo | DRUG | Nebulized placebo |
Key Inclusion Criteria: * Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications * Age ≥ 18 years * FEV1 ≥ 40% predicted * Clinically stable lung disease * Willing and able to provide adequate sputum samples, using any method (spon...
BX004-A is an investigational small molecule developed by BiomX Inc. for chronic Pseudomonas aeruginosa infection in people with cystic fibrosis. It is a nebulized therapy designed to target the bacterium P. aeruginosa. BX004-A has completed a Phase 1 clinical trial and has received Orphan Drug designation from the FDA.
BX004-A is being developed to treat chronic Pseudomonas aeruginosa pulmonary infection in patients with cystic fibrosis. It is administered as a nebulized therapy. The goal is to target and reduce P. aeruginosa bacteria in the lungs. It is investigational and has not been approved for commercial use.
BX004-A targets Pseudomonas aeruginosa, a Gram-negative bacterium that causes chronic lung infections. The drug is a small molecule designed to specifically act against this pathogen. By targeting the bacteria directly, it aims to reduce the bacterial burden in cystic fibrosis patients with chronic P. aeruginosa infection.
BX004-A is being developed by BiomX Inc., a biotechnology company publicly traded under the ticker PHGE. BiomX focuses on developing therapies for infectious diseases. The company is advancing BX004-A as a potential treatment for chronic Pseudomonas aeruginosa infection in cystic fibrosis patients.
BX004-A is in Phase 1 clinical development. It has completed one Phase 1 trial, and no active trials are currently listed. The FDA has granted Orphan Drug designation for BX004-A. It remains an investigational therapy and has not been approved by the FDA.
BX004-A has been evaluated in a completed Phase 1 trial, NCT05010577, titled Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection. The trial enrolled 43 participants across the United States, Czechia, Israel, Netherlands, and Spain. It was randomized, double-blind, and placebo-controlled.