FDA clears expanded access IND for APT’s PhageBank therapy for Covid-19-related bacterial infections

“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.”

Source: Company Press Release