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A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects With Chronic Pseudomonas Aeruginosa (PsA) Pulmonary Infection

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Trial Profile

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects With Chronic Pseudomonas Aeruginosa (PsA) Pulmonary Infection

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 12 Dec 2025

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At a glance

  • Drugs BX 004 (Primary)
  • Indications Pseudomonal infections
  • Focus Therapeutic Use
  • Sponsors BiomX

Most Recent Events

  • 26 Nov 2025 Results published in the Media Release
  • 12 Nov 2025 According to BiomX media release, company received written FDA feedback recognizing the significant unmet need among cystic fibrosis patients treated with CFTR modulators. The FDA outlined potential Phase 3 development pathways, including opportunities for population enrichment and optimized trial design.
  • 19 Aug 2025 According to BiomX media release, U.S. FDA has placed a clinical hold on the Phase 2b study as it reviews data submitted by BiomX on third-party nebulizer used to deliver BX004 and there aren't any concerns raised for the drug BX004. The company have provided data to the FDA that can satisfactorily support the use of the nebulizer so that they can resume CF treatment in US at earliest.

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