In short
P6IHMA-2121908 is an investigational bacteriophage (phage) therapy being studied for chronic Pseudomonas aeruginosa lung infections in people with cystic fibrosis. In the registry it is known as BX004, an inhalation solution developed by BiomX Ltd. One completed Phase 2b trial enrolled 63 participants and measured the change in Pseudomonas aeruginosa bacteria in sputum after 8 weeks of treatment.
Key points
- P6IHMA-2121908 is an investigational phage therapy, not yet authorised as a medicine.
- It is studied in cystic fibrosis with chronic Pseudomonas aeruginosa lung infection.
- The single registered trial was a Phase 2b randomised, double-blind, placebo-controlled study.
- The trial enrolled 63 participants and has been completed.
- The main measure was the change in Pseudomonas aeruginosa bacterial load in sputum after 8 weeks.
- The medicine is given as an inhalation solution via nebuliser.
What is on this page?
- What is P6IHMA-2121908?
- How does P6IHMA-2121908 work?
- Which conditions is P6IHMA-2121908 studied for?
- How is P6IHMA-2121908 given?
- What does the clinical trial show?
- What side effects are known?
What is P6IHMA-2121908?
P6IHMA-2121908 is an investigational bacteriophage (phage) therapy. Bacteriophages are viruses that infect and kill specific bacteria. The substance is developed as a product named BX004 by BiomX Ltd. In the product records it appears under several related names: IHMA-2121771-1, IHMA-2121771-2, IHMA-2121908-1, P37IHMA-2121908, and P6IHMA-2121908. It has no marketing authorisation in these records, meaning it is not yet an approved medicine. The substance is part of a fixed combination in one product record, indicating that BX004 contains more than one phage component.
How does P6IHMA-2121908 work?
Bacteriophages such as P6IHMA-2121908 are viruses that recognise, infect and destroy specific bacterial cells. In this case the target is Pseudomonas aeruginosa, a bacterium that causes chronic lung infections in people with cystic fibrosis. The trial measured the change in Pseudomonas aeruginosa colony-forming units per gram of sputum (CFU/g), which is a way of counting how many live bacteria are present in the mucus coughed up from the lungs. A reduction in this number would indicate that the phage therapy is reducing the bacterial burden in the lungs.
Which conditions is P6IHMA-2121908 studied for?
- Cystic fibrosis — an inherited condition that causes thick mucus to build up in the lungs, leading to repeated and chronic lung infections. In this trial, P6IHMA-2121908 was studied in people with cystic fibrosis who had a chronic Pseudomonas aeruginosa pulmonary infection.
How is P6IHMA-2121908 given?
P6IHMA-2121908 is formulated as an inhalation solution and is given by inhalation. In the trial, participants received 10 millilitres of BX004 by inhalation, which means the solution is turned into a fine mist and breathed into the lungs, typically using a nebuliser.
What does the clinical trial show?
One clinical trial is registered for P6IHMA-2121908: a Phase 2b randomised, double-blind, placebo-controlled study in cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection. The trial enrolled 63 participants and has been completed. Participants were randomised to receive either BX004 or a placebo, both given by inhalation. The primary outcome was the change from baseline in Pseudomonas aeruginosa colony-forming units per gram of sputum at 8 weeks of treatment, which is the end of the treatment period. The trial aimed to assess whether nebulised BX004 reduces the sputum Pseudomonas aeruginosa burden in people with cystic fibrosis who have a chronic lung infection.
What side effects are known?
The registry records for this trial do not include a list of side effects. No supplementary sources with safety information were provided for this page.