Therapy Areas: AIDS & HIV
Adaptive Phage Therapeutics Inks Agreement with ARLG to Support Phase 1b/2 Cystic Fibrosis Study
2 November 2021 - - US-based biotechnology company Adaptive Phage Therapeutics, Inc has entered into an agreement with the Antibacterial Resistance Leadership Group 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, the company said.

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 under Award Number UM1AI104681.

It is facilitated by the Duke Clinical Research Institute and works under a 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 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.

Adaptive Phage Therapeutics is a clinical-stage company advancing therapies to treat multi-drug resistant infections.

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 US 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.
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