First patient has been dosed in the PHAGE clinical trial, evaluating bacteriophage therapy in adults with cystic fibrosis who carry Pseudomonas aeruginosa in their lungs
Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotechnology company developing the APT Phage Bank, the world’s largest therapeutic initiative to treat bacterial infectious diseases, today announced the first patient to receive doses in PHAGE Clinical trial, evaluating phage treatment in adults with cystic fibrosis (CF) who are carriers Pseudomonas aeruginosa (P. aeruginosa) in their lungs.
The trial is evaluating whether the phage, or “phage,” is safe and able to reduce the amount of bacteria in the volunteers’ lungs. The trial takes place before Antibacterial Resistance Leading Group (ARLG) Made up of more than 100 leading experts, they work 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 bacteriophage treatment WRAIR-PAM-CF1 was developed by Walter Reed Army Institute of Research (WRAIR) and licensed and manufactured by APT. The trial is expected to enroll a total of 72 patients at multiple sites across the country.
“At Adaptive Phage Therapeutics, we are committed to developing innovative therapies that address the growing problem of antibiotic resistance,” said Greg Merrill, CEO of Adaptive Phage Therapeutics. “We are proud to be a part of this important trial and look forward to working with ARLG, NIAID, WRAIR and the cystic fibrosis community to give 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 of using phages as treatments, theorizing that mixtures of phages can be used alone, or along with antibiotics, to treat bacterial infections—especially those that are resistant to antibiotics.
P. aeruginosaIt is a serious and sometimes fatal germ that is frequently acquired in healthcare settings, and is the most common bacterial cause of cystic fibrosis exacerbations. P. aeruginosa Tissue damage caused by cystic fibrosis changes in mucus can be taken advantage of to infect and colonize the lungs. Multidrug resistant P. aeruginosa The infection is becoming increasingly common, and in recent years only a handful of new antibiotics have been approved to treat it.
the PHAGE The trial enrolls chronically harboring cystic fibrosis patients P. aeruginosa in their airways. Participants receive WRAIR-PAM-CF1 as a single intravenous infusion at one of three dose levels. The researchers will collect data on safety and microbiological activity; how phages work in the body; how investigational therapy affects lung function in participants; Whether the treatment works differently P. aeruginosa from different geographic regions; and whether the treatment changes the participants’ overall quality of life.