P6IHMA-2121908

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.^[1] In the product records it appears under several related names: IHMA-2121771-1, IHMA-2121771-2, IHMA-2121908-1, P37IHMA-2121908, and P6IHMA-2121908.^[1] It has no marketing authorisation in these records, meaning it is not yet an approved medicine.^[1] The substance is part of a fixed combination in one product record, indicating that BX004 contains more than one phage component.^[1]

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.^[1] 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.^[1]

How is P6IHMA-2121908 given?

P6IHMA-2121908 is formulated as an inhalation solution and is given by inhalation.^[1] 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.^[1]

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.^[1] The trial enrolled 63 participants and has been completed.^[1] Participants were randomised to receive either BX004 or a placebo, both given by inhalation.^[1] 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.^[1] 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.^[1]

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.