The Cystic Fibrosis Foundation has awarded up to $5 million to Armata Pharmaceuticals to advance its potential treatment AP-PA02 — a phage therapy against multidrug-resistant Pseudomonas aeruginosa infections in cystic fibrosis (CF) patients — into a Phase 1b/2 clinical trial.
Phage therapy harnesses the properties of bacteriophages (or phages) — viruses that infect and kill bacteria — to fight bacterial infections that are difficult to treat, particularly those resistant to multiple antibiotics.
The new trial will test the safety, tolerability, and effectiveness of AP-PA02 in CF patients chronically infected with P. aeruginosa.
“We are pleased that the Cystic Fibrosis Foundation recognizes the potential of phage-based therapeutics as a potential treatment for Pseudomonas airway infections, which are a major cause of morbidity and mortality in people with CF,” Todd R. Patrick, CEO of Armata, said in a press release.
“We are working vigorously to advance AP-PA02 through clinical development as efficiently as possible. We are grateful for the Foundation’s support,” he added.
Phages are usually used on a case-by-case basis, as detailed and rigorous studies are needed to assess if this therapy can be safely and effectively used in people with CF.
AP-PA02 is a novel, second version of the company’s candidate AP-PA01, which was previously shown to successfully treat a CF patient. After 100 days of treatment with the compound, combined with antibiotics, the patient was free of P. aeruginosa pneumonia and CF flares.
“Following the promising results reported through several individual cases, we are pursuing rigorous studies to evaluate the safety and efficacy of this emerging area of science,” Michael P. Boyle, MD, president and CEO of the Cystic Fibrosis Foundation, said in another press release. “Better understanding of phage therapy has potential to significantly benefit people with CF as well as millions of others worldwide who are impacted by antibiotic-resistant infections.”
AP-PA02 is a mixture of multiple phages, which was developed to be inhaled, selected from Armada’s phage library, and tested in hundreds of P. aeruginosa samples from CF patients. With this approach, the candidate compound is thought to have a wider targeting range, increased potency, and potential to prevent the development of resistance.
According to the company, tests in the laboratory have shown that AP-PA02 is able to kill more than 80% of Pseudomonas strains in people with CF.
“The CF community continues to need novel approaches to serious lower airway infections,” said Christopher H. Goss, MD, of the Seattle Children’s Research Institute, and professor of medicine and pediatrics at the University of Washington, who will serve as the lead principal investigator in the Phase 1b/2 clinical trial. “I am excited to be working with Armata and look forward to the launch of this important clinical study.”
The trial is the first in the U.S. to study phage therapy outside the Food and Drug Administration emergency Investigational New Drug process.
Armata plans to conduct the study within the Cystic Fibrosis Therapeutics Development Network, the largest network of CF clinical trials in the world.
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