November 02, 2020 11:00 AM Eastern Standard Time
- Eight COVID-19 + CRAB 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 and its partners are currently self-funding emergency use of PhageBank™ in this patient group, and are seeking US government support to substantially increase the availability of PhageBank™ treatment 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 carbapenem resistant Acinetobacter baumannii (CRAB) bacteria in COVID-19 patients. Mortality rates were more than two-fold higher in COVID-19 patients with secondary CRAB infection, versus 32% mortality in patients without secondary CRAB infections.
In late September the DHR Health Institute for Research and Development (DHRHIRD), which established the Rio Grande Valley Collaborative (RGVC) involving 11 healthcare facilities in South Texas to combat the COVID-19 pandemic, identified this evolving challenge and reached out to the Center for Innovative Phage Applications and Therapeutics at UC San Diego School of Medicine and the Walter Reed Army Institute of Research (WRAIR), Bacterial Diseases Branch, to determine if bacteriophage therapy would be a viable option to treat these patients. WRAIR and APT joined forces to respond to this outbreak. APT, in collaboration with its WRAIR partners, identified two bacteriophage active against bacterial isolates from hospitalized patients. APT continues to receive CRAB isolates from new patients on a daily basis for analysis and phage matching to enable compassionate use of PhageBank™. While the CRAB isolates have been extensively drug resistant (XDR), APT’s PhageBank™ therapy has been found to kill those bacteria in vitro .
As of today, eight COVID-19 patients in South Texas with CRAB have received PhageBank™ therapy under U.S. Food and Drug Administration (FDA) emergency allowance (eIND). In collaboration with their collaborators Dr. Benjamin Chan, Yale University and Dr. Jonathan Koff from Yale University School of Medicine, the treating physicians hope to provide nebulized therapy in addition to IV PhageBank™ therapy.
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 COVID-19 patients, across the United States.
“The RGVC has documented increasing mortality in COVID-19 patients with CRABinfections, 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 largely 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, hundreds of hospitalized patients may be at risk for secondary antibiotic-resistant bacterial infections that increase mortality. At present, APT, WRAIR, and their partners are addressing this unmet need entirely with their own resources.”
“Partnership with APT and WRAIR has provided us with a unique opportunity to offer an innovative option to treat CRAB in patients with multiple co-morbidities,” said Sohail Rao, MD, MA, DPhil, President & CEO, DHRHIRD. “It is envisioned that the use of bacteriophage may reduce the burden of CRAB, giving patients a chance to recover from the debilitating effects of COVID-19.”
“We are pleased to have been able to successfully deploy our investigational PhageBank™ therapy in response to this outbreak in 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 with a variety of infections have now been treated using our PhageBank™, 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 provide additional treatment options to physicians managing difficult-to-treat 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 growing 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 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.
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