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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 being developed for chronic Pseudomonas aeruginosa infection, specifically in cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection. It is administered as a nebulized bacteriophage therapy and is currently in Phase 1 clinical development.
BX004-A targets Pseudomonas aeruginosa, a bacterium that causes chronic pulmonary infections in cystic fibrosis patients. The therapy is designed to treat this specific bacterial infection, which is a significant cause of morbidity in the cystic fibrosis population.
BX004-A is being developed by BiomX Inc., a biopharmaceutical company. BiomX is focused on developing therapies for infectious diseases, and BX004-A is one of its investigational candidates for chronic Pseudomonas aeruginosa infection.
BX004-A is in Phase 1 clinical development. It has completed a Phase 1 trial, and it is not yet approved by the FDA. The drug has received Orphan Drug and Fast Track designations from the FDA, which are intended to expedite its development and review.
BX004-A has been studied in a Phase 1 clinical trial with the identifier NCT05010577. This trial was a randomized, double-blind, placebo-controlled study that evaluated nebulized bacteriophage therapy in cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection. The trial enrolled 43 participants and was conducted in the United States, Czechia, Israel, Netherlands, and Spain.
Yes, BX004-A is a bacteriophage therapy. It is a nebulized formulation designed to treat chronic Pseudomonas aeruginosa infection in cystic fibrosis patients. The therapy uses bacteriophages, which are viruses that specifically infect and kill bacteria, to target the Pseudomonas aeruginosa infection.