GlobeNewswire·Nov 25, 2025, 4:40 PM ET

BiomX Provides Update on BX004 Phase 2b Trial in Cystic Fibrosis

BiomX is working with a third-party manufacturer to address FDA information requests required to lift the clinical hold on the nebulizer device used in the BX004 Phase 2b trial.
An independent Data Monitoring Committee completed a safety review of the BX004 Phase 2b trial after adverse events occurred & recommended the study continue with an adjusted dosing regimen.
The study protocol will be updated to reflect the DMC's recommendations on the revised dosing plan.
Topline results for the BX004 Phase 2b trial are now expected in the second quarter of 2026, pending financial resources & resolution of the FDA hold.
U.S. patient enrollment is expected to resume once the FDA clinical hold regarding the nebulizer device is lifted.
BX004 is a multi-phage cocktail targeting Pseudomonas aeruginosa in cystic fibrosis patients & holds Fast Track & Orphan Drug Designations from the FDA.
The Phase 2b trial aims to enroll up to 60 patients in a randomized, double-blind, placebo-controlled, multi-center study over an 8-week period.