The Cystic Fibrosis Foundation has announced a grant of up to $5 million to BiomX Inc. for a phase 1b/2a clinical trial to test the safety and tolerability of bacteriophage (phage therapy) in treating Pseudomonas aeruginosa infections in people living with cystic fibrosis.

Currently, people with CF can access phage treatment in the United States only through the Food and Drug Administration’s emergency Investigational New Drug process, which allows the use of experimental therapies for life-threatening conditions. The clinical trial of BX004, a cocktail of different types of phages designed to target a broad range of Pseudomonas bacteria strains, will test for safety, clinical activity, and drug metabolism in eight CF patients, then evaluate the safety and efficacy of BX004 in twenty-four patients.

“Developing new approaches to treat drug-resistant bacteria is critical as many people with CF struggle with difficult-to-treat infections,” said CFF vice president of clinical research JP Clancy. “Although promising results have been reported in several individual cases, studies like this one will help us evaluate the safety and efficacy of phage as a potential therapy.”

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