Study With Phage for CF Subjects With Pseudomonas Lung Infection

Prior treatment

• Receipt of prior bacteriophage therapy within the 6 months prior to Screening or Day 1
• Detection of Burkholderia cenocepacia from respiratory tract within 1 year prior to Screening or from Screening culture
• Currently receiving systemic treatment for allergic bronchopulmonary aspergillosis
• Currently receiving treatment for active infection with non-tuberculous mycobacteria or prior detection of Mycobacterium abscessus in 12 months prior to Screening
• Initiation or change in type of CFTR modulator less than 3 months prior to Screening

Other illness

• Known hypersensitivity to bacteriophages or excipients in the formulation.
• History of severe neutropenia
• History of lung transplant
• History of solid organ transplant
• Acquired or primary immunodeficiency syndrome

Other

• Pregnant or breastfeeding female

• Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care inhaled antibiotics (cycling or continuous regimen) or no inhaled antibiotics
• Age ≥ 18 years
• FEV1 40%-80% 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.