In short
P37IHMA-2121908, also known as BX004, is an investigational substance with no marketing authorisation. It is a phage therapy being studied for cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection. One completed Phase 2b trial enrolled 63 participants to test whether inhaled BX004 could reduce Pseudomonas bacteria in sputum.
Key points
- P37IHMA-2121908 is an investigational phage therapy, also known as BX004.
- It is being studied in cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection.
- One Phase 2b trial has been completed with 63 participants.
- The trial measured the change in Pseudomonas aeruginosa CFU/g of sputum after 8 weeks of treatment.
- BX004 is given as an inhalation solution.
- The substance has no marketing authorisation and remains investigational.
What is P37IHMA-2121908?
P37IHMA-2121908 is an investigational substance that belongs to a class of treatments called phage therapies. It is also known under the product name BX004 and appears in registry records under several development codes, including IHMA-2121771-1, IHMA-2121771-2, IHMA-2121908-1, and P6IHMA-2121908. The substance has no marketing authorisation in the product records, meaning it is not yet approved as a medicine. It is supplied by BiomX Ltd. and is recorded as a test substance in one clinical trial. The substance is classified in the therapeutic area of respiratory tract diseases.
How does P37IHMA-2121908 work?
P37IHMA-2121908 is a phage therapy, which means it uses bacteriophages — viruses that specifically infect and kill bacteria. The trial data indicate that BX004 is designed to target Pseudomonas aeruginosa, a bacterium that causes chronic lung infections in people with cystic fibrosis. The primary outcome measured in the trial was the change in Pseudomonas aeruginosa colony-forming units per gram of sputum, which reflects how many live bacteria remain in the airways. No further details on the molecular mechanism are provided in the available sources.
Which conditions is P37IHMA-2121908 being studied for?
- Cystic fibrosis — a genetic condition that affects the lungs and other organs, in which thick mucus builds up and can lead to chronic bacterial infections. The trial studied people with cystic fibrosis who had chronic Pseudomonas aeruginosa pulmonary infection.
How is P37IHMA-2121908 given?
P37IHMA-2121908 is formulated as an inhalation solution and is given by inhalation. In the completed trial, the dose studied was 10 millilitres administered by inhalation. The product records also indicate that in one record the substance is part of a fixed combination.
What do the clinical trials show?
One clinical trial of P37IHMA-2121908 has been completed. It was a Phase 2b randomised, double-blind study that enrolled 63 participants with cystic fibrosis and chronic Pseudomonas aeruginosa lung infection. The trial compared inhaled BX004 against a placebo. The primary endpoint was the change from baseline in Pseudomonas aeruginosa colony-forming units per gram of sputum after 8 weeks of treatment, measured at day 57, the end of treatment. The study status is completed, but the registry records do not include the results of this endpoint.
The trial enrolled 63 participants, making it a moderately sized Phase 2b study. Participants were people with cystic fibrosis who had chronic Pseudomonas aeruginosa pulmonary infection. The trial was interventional and double-blind, meaning neither participants nor researchers knew who received the phage therapy and who received placebo.
What side effects are known?
The available sources do not provide information on side effects of P37IHMA-2121908. The trial registry record does not list adverse events, and no supplementary sources with safety data were included.