Gaithersburg-based Adaptive Phage Therapeutics, Inc., (APT) a clinical-stage biotechnology company (located at 708 Quince Orchard Rd) advancing the APT phage bank, the world’s largest therapeutic phage initiative for treatment of bacterial infectious diseases, announced the first patient has been dosed in the PHAGE clinical trial, evaluating bacteriophage therapy in adults with cystic fibrosis (CF) who carry Pseudomonas aeruginosa (P. aeruginosa) in their lungs. The trial is evaluating whether the bacteriophage, or “phage,” therapy is safe and able to reduce the amount of bacteria in the lungs of volunteers. The trial is being conducted by the Antibacterial Resistance Leadership Group (ARLG) which consists of more than 100 leading experts, working together to combat the ongoing antibacterial resistance crisis and improve patient care. ARLG is funded by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). The investigational phage therapeutic, WRAIR-PAM-CF1, was developed by the Walter Reed Army Institute of Research (WRAIR) and is licensed to and manufactured by APT. The trial is expected to enroll a total of 72 patients at multiple sites across the country.
Per the press release: “At Adaptive Phage Therapeutics, we are committed to developing innovative treatments that address the growing problem of antibiotic resistance,” said Greg Merril, CEO of Adaptive Phage Therapeutics. “We are proud to be a part of this important trial and look forward to working with the ARLG, NIAID, WRAIR, and the CF community to bring new hope to those affected by this devastating disease and secondary respiratory infection.”
Phages are viruses that can kill or neutralize specific bacteria while leaving non-target bacteria and human cells unharmed. For more than a century, researchers have considered the potential use of phages as therapeutics, theorizing that mixtures of bacteriophages might be used on their own, or in conjunction with antibiotics, to treat bacterial infections—especially those resistant to antibiotics.
P. aeruginosa, a serious and sometimes deadly bacterium frequently acquired in healthcare settings, is the most common bacterial cause of CF exacerbations. P. aeruginosa can take advantage of the tissue damage caused by CF changes in mucus to infect and colonize the lungs. Multidrug-resistant P. aeruginosa infections are becoming increasingly common, and in recent years, only a handful of new antibiotics have been approved to treat them.
The PHAGE trial is enrolling CF patients who chronically harbor P. aeruginosa in their respiratory tracts. Participants receive WRAIR-PAM-CF1 as a single IV infusion at one of three dosage levels. Researchers will gather data on safety and microbiological activity; how the phages function in the body; how the investigational therapy affects the participants’ lung function; whether the therapy works differently on P. aeruginosa from different geographical regions; and whether the therapy changes participants’ overall quality of life.
About the Walter Reed Army Institute of Research (WRAIR)
WRAIR, part of the U.S. Army Medical Research and Development Command under the Army Futures Command, provides unique research capabilities and innovative medical solutions to a range of Force Health Protection and Readiness challenges currently facing U.S. Service Members, along with threats anticipated during future operations. For more information about the Walter Reed Army Institute of Research, visit https://wrair.health.mil/.
About The Antibacterial Resistance Leadership Group (ARLG)
The ARLG is a clinical research consortium supported by NIAID which works to combat the antibacterial resistance crisis and improve patient care. ARLG’s mission is to prioritize, design, and execute clinical research that will impact the prevention, diagnosis, and treatment of infections caused by antibiotic-resistant bacteria. It is facilitated by the Duke Clinical Research Institute and works under the leadership of an executive committee, four component centers, and two Principal Investigators: Vance Fowler, MD, of Duke University, and Henry “Chip” Chambers, MD, of University of California, San Francisco. For more information about this trial, visit ClinicalTrials.gov and search identifiers NCT05453578.
About the National Institutes of Health (NIH)
NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.