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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: 22 Aug 2025

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At a glance

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

Most Recent Events

  • 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.
  • 19 Aug 2025 According to BiomX media release, the patient screening and enrollment in the U.S. portion has been paused and in EU the study has been approved and enrollment and dosing of patients is continuing in accordance with the protocol.
  • 18 Jul 2025 Status changed from not yet recruiting to recruiting.

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