Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1b/2a study with the primary objective to determine if BX004-A is safe and tolerable. Exploratory objectives include whether BX004-A reduces sputum Pseudomonas aeruginosa (PsA) bacterial load in CF subjects with chronic PsA pulmonary infection.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BiomX, Inc.

Criteria

Key Inclusion Criteria:

• Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications

• Age ≥ 18 years

• FEV1 ≥ 40% predicted

• Clinically stable lung disease

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

Key Exclusion Criteria:

• Known hypersensitivity to bacteriophages or excipients in the formulation.

• Receipt of prior bacteriophage therapy within the 6 months prior to Screening

• Recovery of Burkholderia species from respiratory tract within 2 years prior to screening

• Currently receiving treatment for allergic bronchopulmonary aspergillosis

• Currently receiving treatment for active infection with non-tuberculous mycobacteria

• History of severe neutropenia

• History of lung transplant

• History of solid organ transplant

• Acquired or primary immunodeficiency syndrome

• Initiation or change in CF modulator therapy less than 3 months prior to screening

• Pregnant or breastfeeding female