BiomX Inc. (PHGE), a clinical stage biopharmaceutical company, announced that an independent Data Monitoring Committee has completed a safety review of adverse events reported in its Phase 2b trial of BX004 in cystic fibrosis.
The independent Data Monitoring Committee has recommended that the study continue with revised dosing. Accordingly, the study protocol will be updated, and topline results are now expected in Q2 2026.
BX004 is a cocktail of bacteriophage delivered via nebulizer.
The company is also continuing to work with the third-party manufacturer to address recent FDA follow-up information requests which are required to lift the clinical hold concerning the nebulizer device used in the Phase 2b trial of BX004.
The U.S. regulatory agency placed a clinical hold on the Phase 2b trial of BX004 for cystic fibrosis this August due to issues related to the third-party nebulizer used to administer the treatment. As a result, patient screening and enrollment in the U.S. have been halted. However, recruitment and dosing in Europe have continued and are progressing ahead of schedule.
The company believes the additional information requested by the FDA is readily addressable and anticipates that U.S. enrollment will resume once this process is completed.
"We are encouraged by the DMC's conclusion that the BX004 study may continue once the adjusted dosing regimen has been implemented," said Jonathan Solomon, Chief Executive Officer of BiomX.
CF disease, or cystic fibrosis, is a progressive, inherited genetic disorder that causes the body to produce abnormally thick and sticky mucus, leading to blockages and damage in the lungs, digestive system, and other organs.
Approximately 40,000 children and adults in the US have cystic fibrosis according to the National Institutes of Health and the American Lung Association.
PHGE has traded in a range of $4.66 to $22.06 in the last 1 year. The stock closed yesterday's trading at $5.78, up 5.37%. In premarket trading today, PHGE is down 2.25% at $5.65.
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