Armata will use the funding to conduct a Phase 1b/2 clinical trial to test the safety and tolerability of bacteriophage (phage) therapy in Pseudomonas aeruginosa infections in people living with cystic fibrosis. It is the first randomized, controlled clinical trial of phage in cystic fibrosis. Currently, people with CF can only access phage treatment in the U.S. by using the Food and Drug Administration emergency Investigational New Drug process, which allows the use of experimental therapies for life-threatening conditions.
Pseudomonas infections, which are the second most common type of lung infection in people with CF, are very difficult to eliminate once established in the airways. Approximately 44 percent of the nearly 31,000 people with CF in the Cystic Fibrosis Foundation Patient Registry had Pseudomonas infections in 2018, and nearly 17 percent of those infected had multi-drug-resistant Pseudomonas infections.
Bacteriophages are specialized viruses that kill very specific bacterial strains. They are found abundantly in the environment and are the predators of bacteria in nature. “Phage therapy” refers to the use of these bacteriophages to treat an infection in a person. Phage therapy has been used previously on a case-by-case basis to treat people with CF. Rigorous clinical studies are needed to assess the safety and efficacy of phage for potential wider use in CF.
Armata Pharmaceuticals has developed AP-PA02, a mix of multiple different types of phages that is intended to be inhaled. In lab tests conducted by the company, it was able to kill more than 80 percent of Pseudomonas strains from people with CF.
For additional information, please see the CF Foundation's press release.
The CF Foundation's Commitment to Infection Research
People with CF who have chronic infections are at greater risk for worsening lung disease, and infection remains a top concern of both patients and clinicians. Many individuals also suffer severe side effects from long-term antibiotic use, such as hearing loss, and are at increased risk of developing antibiotic-resistant infections.
In 2018, the CF Foundation dedicated at least $100 million to its Infection Research Initiative as part of a sweeping effort to advance infection research. The Infection Research Initiative is a comprehensive approach to improve outcomes associated with infections through enhanced detection, diagnosis, prevention, and treatment. Currently, the CF Foundation is funding more than 10 industry programs to develop treatments for CF-related infections and is in contact with additional companies as well as academic researchers considering the use of developing phage therapies for CF.