GAITHERSBURG, MD, November 2, 2021 – Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced that it has entered into an agreement with the Antibacterial Resistance Leadership Group (ARLG) to support a multi-center Phase 1b/2, randomized, double-blind, placebo-controlled trial assessing the safety and microbiological activity of a single dose of bacteriophage therapy in cystic fibrosis subjects colonized with Pseudomonas aeruginosa.
ARLG consists of more than 100 leading experts, working together to combat the ongoing antibacterial resistance crisis and improve patient care. Created in 2013, ARLG is funded by a grant from the National Institute of Allergy and Infectious Diseases (NIAID) part of the National Institutes of Health (NIH) under Award Number UM1AI104681. 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. The NIAID is the Sponsor of this study.
Under the agreement, APT will provide proprietary bacteriophages for use in the NIAID sponsored Phase 1b/2 clinical study. Dr. Pranita D. Tamma, MD, MHS, Associate Professor of Pediatrics at the Johns Hopkins University School of Medicine, and Robert "Chip" Schooley, MD, Professor of Medicine at the University of California, San Diego, are serving as the ARLG Protocol Principal Investigators for this Phase 1b/2 study. Specifically, bacteriophages will be provided from the biorepository APT recently acquired under a licensing agreement with Walter Reed Army Institute of Research (WRAIR). WRAIR screened a library of bacteriophage against a large number of P. aeruginosa strains including isolates from persons with cystic fibrosis and developed a four bacteriophage 'cocktail' with a high likelihood of activity against P. aeruginosa clinical isolates. In addition, APT will complete bacteriophage qualification studies using the company's PhageBank™ Susceptibility Test (PST) on clinically relevant Pseudomonas aeruginosa isolates. Following these susceptibility studies, APT will manufacture and supply bacteriophages for use in the Phase 1b/2 clinical trial. After completion of the study and analysis of the results, APT may utilize the study data to move into a pivotal study to advance this program with a goal of FDA licensure and broad market availability.
"We are honored and excited to partner with ARLG as they undertake efforts to address a significant unmet medical need related to cystic fibrosis. ARLG shares our conviction in the possibility of phage to treat a range of multidrug-resistant infections and this Phase 1b/2 trial will act as important clinical proof of concept for that thesis," said Greg Merril, APT's Chairman and Chief Executive Officer. "APT's in vitro assay gives us confidence that the phages selected for this study will cover strains of bacteria that are clinically relevant. Through FDA emergency use allowance, we have observed the potential of phage therapy as an effective treatment for cystic fibrosis patients with Pseudomonas aeruginosa lung infections."
"ARLG's stated mission is to prioritize, design, and execute clinical research that will impact the prevention, diagnosis, and treatment of infections caused by antibiotic-resistant bacteria. There are few patient populations more at risk of antibiotic resistant infections than cystic fibrosis patients, where scarce treatment options exist due to the need for almost continuous antibiotic use," said Vance Fowler, MD, MHS, Duke University School of Medicine, member of the Duke Clinical Research Institute and ARLG Co-Principal Investigator. "As such, the evergreen promise of phage is particularly relevant in this setting, which is why we have partnered with APT and chosen cystic fibrosis subjects colonized with Pseudomonas aeruginosa as our proof-of-concept study."
"Today's announcement demonstrates the strengths of ARLG, as a government agency-sponsored partnership between academia, medical centers and private industry," said Chip Schooley, MD, Distinguished Professor and Chief of the Division of Infectious Diseases in the UC San Diego School of Medicine. "The planned trial could act as an important proof of concept for phage therapy, with implications for additional disease and patient groups, as well as act as a springboard for the development of a new treatment option for cystic fibrosis patients."
"We are delighted to be involved in this important study for treating lung infections in cystic fibrosis patients," said Robin Patel, MD, Director, Laboratory Center, Antibacterial Resistance Leadership Group. "We are committed to exploring the promise of novel therapeutics, the need for which is especially clear among cystic fibrosis patients who face a paucity of treatment options for Pseudomonas aeruginosa infections."
Adaptive Phage Therapeutics, Inc.
Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies to treat multi-drug resistant infections. Prior antimicrobial therapeutic approaches have been "fixed," while pathogens continue to evolve resistance to each of those therapeutics, causing those drug products to become rapidly less effective in commercial use as antimicrobial resistance (AMR) increases over time.
APT's PhageBank™ approach leverages an ever-expanding library of bacteriophage (phage) that collectively provide evergreen broad spectrum and polymicrobial coverage. PhageBank™ phages are matched through a proprietary phage susceptibility assay that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale.
APT's technology was originally developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under FDA emergency Investigational New Drug allowance, APT has provided investigational PhageBank™ therapy to treat more than 40 critically ill patients in which standard-of-care antibiotics had failed.
For more information, visit http://www.aphage.com.
Adaptive Phage Therapeutics
Investor Relations:Gilmartin Group, LLC.: Laurence Watts