Phase 2b Randomized, Double-Blind Study with Phage for CF Subjects with Pseudomonas Lung Infection

Prior treatment

• Initiation or change in type of CFTR modulator less than 3 months prior to Screening
• Receipt of prior bacteriophage therapy within 6 months prior to Screening or Day 1
• Detection of Burkholderia cenocepacia within 1 year prior to Screening or 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

Other illness

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

Other

• Pregnant or breastfeeding female

• Cystic fibrosis patients with chronic Pseudomonas aeruginosa (PsA) pulmonary infection receiving standard of care CF medications
• Age at least 18 years
• FEV1 between 40-80% predicted
• Clinically stable lung disease
• On inhaled antibiotics for Pseudomonas aeruginosa either as a cycling regimen OR continuous regimen (OR no antibiotics)
• Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated or induced, from home or clinic) at study visits