13 January 2023 - - The first patient has been dosed in the PHAGE clinical trial, evaluating bacteriophage therapy in adults with cystic fibrosis who carry Pseudomonas aeruginosa (P. aeruginosa) in their lungs, US-based biotechnology company Adaptive Phage Therapeutics, Inc said.

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 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.

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.

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.

The Walter Reed Army Institute of Research (WRAIR) is part of the US Army Medical Research and Development Command under the Army Futures Command.

It provides unique research capabilities and innovative medical solutions to a range of Force Health Protection and Readiness challenges currently facing US Service Members, along with threats anticipated during future operations.

The Antibacterial Resistance Leadership Group is a clinical research consortium supported by NIAID which works to combat the antibacterial resistance crisis and improve patient care.

NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the US 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.

Adaptive Phage Therapeutics is a clinical-stage company advancing therapies to treat multidrug-resistant infections based on a phage bank concept originally initiated at the National Institutes of Health by APT co-founder Carl R. Merril, M.D., Capt.

APT is the sponsor of ongoing clinical trials in Prosthetic Joint Infection and Diabetic Foot Osteomyelitis, addressing notable unmet patient needs in those bacterial infection indications.

APT's phage bank has also been used in over 50 compassionate cases under FDA emergency Investigational New Drug allowance in which standard-of-care antibiotics had failed.

APT phage bank is paired with a phage susceptibility test that matches each patient bacterial isolate to specific lytic phage within APT's collection analogous to an antibiotic susceptibility test for matching antibiotics.

The APT PST will be commercialized worldwide in collaboration with Mayo Clinic Laboratories.