Policy & Regulation
FDA Clears Expanded Access IND for APT's PhageBank Therapy to Combat COVID-19-related Bacterial Infections
19 November 2020 - - US-based biotechnology company Adaptive Phage Therapeutics has obtained clearance by the US Food and Drug Administration of the company's Expanded Access IND for PhageBank treatment for pneumonia or bacteremia/septicemia due to Acinetobacter baumannii, Pseudomonas aeruginosa or Staphylococcus aureus in COVID-19 patients, the company said.

APT and its partners, including the Walter Reed Army Institute of Research (WRAIR), were the first to respond to this crisis in COVID-19 patients and are well positioned to address the additional pathogens of S. aureus and P.aeuroginosa covered under the scope of this Expanded Access IND.

On November 2, 2020, APT reported a deployment of its investigational PhageBank therapy in Texas in response to a deadly outbreak of secondary infections with carbapenem resistant A. baumannii (CRAB) bacteria in COVID-19 patients, where mortality rates were more than two-fold higher in COVID-19 patients with secondary CRAB infection relative to the mortality rate in patients without infection.

Adaptive Phage Therapeutics 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 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 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 30 critically ill patients in which standard-of-care antibiotics had failed.