BX004 for Cystic Fibrosis

Recruiting at 10 trial locations

Overseen By Urania Rappo, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: BiomX Ltd

Must be taking: Inhaled antibiotics

Must not be taking: Systemic antifungals

Disqualifiers: Lung transplant, Immunodeficiency, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

63 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this Phase 2b clinical trial is to see if nebulized phage (BX004) can treat chronic Pseudomonas aeruginosa (PsA) lung infection in CF subjects. The primary goal is to see if 8 weeks of twice daily BX004 can reduce the amount of PsA in the sputum compared to placebo (on top of background CF therapy).

Research Team

Urania Rappo, MD

Principal Investigator

BiomX, Inc.

Eligibility Criteria

This trial is for individuals with Cystic Fibrosis (CF) who have a chronic lung infection caused by Pseudomonas aeruginosa. Participants should be on stable CF therapy and able to provide sputum samples. Specific eligibility criteria are not provided, but typically include age range, disease severity, and absence of conditions that could interfere with the study.

Inclusion Criteria

I am 18 years old or older.

FEV1 40%-80% predicted

Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated, induced, from home or clinic) at designated study visits.

Exclusion Criteria

Known hypersensitivity to bacteriophages or excipients in the formulation

Detection of Burkholderia cenocepacia from respiratory tract within 1 year prior to Screening or from Screening culture

History of lung transplant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nebulized phage (BX004) or placebo twice daily for 8 weeks

8 weeks

Multiple visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Regular follow-up visits

Treatment Details

Interventions

• BX004

Trial Overview The trial is testing BX004, a nebulized phage therapy designed to treat Pseudomonas aeruginosa infections in the lungs of CF patients. Over 8 weeks, participants will inhale BX004 or a placebo twice daily to see if there's a reduction in bacterial levels in their sputum.

Participant Groups

Group I: BX004 Experimental Treatment 1 Intervention

Participants will be randomized to receive standard dose of nebulized bacteriophage

Group II: Placebo Placebo Group 1 Intervention

Participants will be randomized to receive nebulized placebo

Who Is Running the Clinical Trial?

BiomX Ltd

Lead Sponsor