Nine COVID-19 patients have received PhageBank™ therapy under FDA-approved emergency allowance, with more anticipated
- Nine COVID-19 patients have received PhageBank™ therapy under FDA-approved emergency allowance, with more anticipated
- Significant increased mortality has been observed from secondary CRAB infections in COVID-19 patients
- APT currently self-funding emergency use of PhageBank™ in this patient group, and is seeking US government support to substantially increase PhageBank™ treatment availability to better combat secondary bacterial outbreaks in these COVID-19 patients
GAITHERSBURG, Md.--(BUSINESS WIRE)-- Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced a deployment in Texas of its investigational PhageBank™ therapy in response to a deadly outbreak of secondary infections with carbapenemase resistant Acinetobacter baumannii (CRAB) bacteria in ventilated COVID-19 patients.
As of today, nine COVID-19 patients in Texas have received PhageBank™ therapy under U.S. Food and Drug Administration (FDA) emergency allowance (eIND). Prior to the use of PhageBank™ therapy in this patient group, mortality rates were approaching 100% for ventilated COVID-19 patients with secondary CRAB infection, versus 32% mortality in patients without secondary bacterial infections.
While the CRAB bacteria has been found resistant to all tested antibiotics, APT’s PhageBank™ therapy is the only therapy found to eradicate the bacteria based on in vitro testing.
APT is actively working with the FDA to enable enhanced access to PhageBank™-based therapies in COVID-19 patients, while simultaneously pursuing government funding to expand its PhageBank™ delivery capacity to meet the substantial anticipated demand, to better treat these ventilated COVID-19 patients, across the United States.
“Authorities in Texas have documented increasing mortality in COVID-19 patients with CRAB infections, a Center for Disease Control (CDC) reportable event. As a result, APT believes mortality from phage-treatable secondary bacterial infections in other regions of the United States may be substantially underreported, given the immense stress and workload ICUs currently face due to COVID-19 patients,” said Subhendu Basu, Ph.D., Chief Operating Officer, APT. “The U.S. healthcare system’s Herculean efforts to expand and redirect medical resources in this pandemic have mostly focused on increasing availability and use of personal protective equipment, diagnostics, and ventilators, while developing and/or testing new vaccines, therapeutics and other treatment modalities. However, now that COVID-19-related hospital admissions rates are rising again across the country, it appears that hundreds of currently hospitalized patients may be highly susceptible to the adverse effects of secondary antibiotic-resistant bacterial infections that exacerbate mortality. At present, APT is addressing this unmet need entirely with its own resources.”
“We are pleased and relieved to have been able to successfully deploy our investigational PhageBank™ therapy in response to this outbreak in ventilated COVID-19 patients in Texas. Our PhageBank™ deployment represents the first time our technology, originally developed by the Department of Defense, has been used to treat multidrug-resistant secondary bacterial infections in COVID-19 patients,” said Greg Merril, APT’s CEO and co-founder. “Over 30 patients worldwide have now been treated using our PhageBank™ across a variety of clinical indications, including prosthetic joint infections and chronic lung infections.”
Greg Merril continued, “APT is working closely with the FDA to expand early access to our investigational PhageBank™ therapy in order to maintain our ability to help prevent loss of life from secondary multidrug resistant infections, especially against the backdrop of continuing high levels of COVID-19-related hospitalizations. We are in dialogue with multiple U.S. government funding agencies to obtain their support to expand our PhageBank™ operational capability while meeting this high and increasing demand to treat antibiotic resistant secondary bacterial infections in the ever-increasing U.S. COVID-19 population.”
Adaptive Phage Therapeutics, Inc.
Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies to treat multi-drug resistant infections. Prior approaches in antimicrobials have been ‘fixed’ while the pathogens continue to evolve resistance - therefor all have either become obsolete or are becoming obsolete due to antimicrobial resistance (AMR). 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.
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Source: Adaptive Phage Therapeutics
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