FDA Clears Expanded Access IND for APT’s PhageBank™ Therapy to Combat COVID-19-related Bacterial Infections

GAITHERSBURG, Md.–([1])–Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat multi-drug resistant bacterial infectious diseases, today announced clearance by the U.S. Food and Drug Administration (FDA) 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 FDA’s decision supports our ability to provide a new treatment option for critically ill COVID-19 patients with bacterial infections resistant to nearly all other available therapies. This COVID-19 patient population is rapidly increasing in line with the overall number of hospitalized COVID-19 patients. As a result, APT expects requests for PhageBank™ therapy to address this critical unmet need to continue to increase in the coming months,” said Subhendu Basu, Ph.D., Chief Operating Officer, APT. “Importantly, once sufficient treatment data is available, we plan to request a meeting with the FDA to raise the possibility of an Emergency Use Authorization (EUA) for PhageBank™ therapy in COVID-19 patients with suspected or confirmed secondary bacterial infections.”

“Since September 2020, APT’s PhageBank™ therapy has been used to treat 9 COVID-19 patients in South Texas with co-infections due to multi-drug resistant Acinetobacter baumannii under the emergency IND mechanism,“ said Sohail Rao, M.D., M.A., D.Phil, President & CEO, DHR Health Institute for Research & Development. “All patients were ventilated and all had significant co-morbidities. The availability of phage therapy allowed us to reduce the burden of multi-drug resistant Acinetobacter baumannii infection in these patients.”

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. “WRAIR has a collection of highly curated and potent bacteriophage against P.aeruginosa that we will be contributing to this effort,” said Lieutenant Colonel Brett Swierczewski of WRAIR’s Bacterial Diseases Branch. “These phages have been screened against panels of over 200 multidrug resistant isolates created from WRAIR’s Multidrug Resistant Organism Repository and Surveillance Network (MRSN) repository and have demonsrated broad coverage. We look forward to working with APT to continue addressing this urgent situation.”

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.

“Two weeks ago, when we announced the deployment of PhageBank™ in Texas, we detailed a two-tiered strategy to deal with the ongoing crisis, which to date has been covered entirely by APT and our partners. First, we sought to streamline the regulatory process for critically ill patients to gain access to PhageBank™ phage therapy, and I am incredibly grateful to the FDA for their timely review and approval of an Expanded Access IND for PhageBank™ to make that a reality,” said Greg Merril, APT’s CEO and co-founder. “We are now focused on the second part of our strategy, to continue seeking funding from a number of U.S. government agencies to underpin the current and future readiness of our PhageBank™ capability. Without such funding, our ability to meet the growing demand to treat antibiotic-resistant secondary bacterial infections in the ever-increasing U.S. COVID-19 population remains uncertain. We are hopeful that our ongoing discussions with a variety of government and non-governmental bodies will result in our ability to continue to meet this urgent medical need in our country.”

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

For more information, visit http://www.aphage.com[2].

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