FDA approves phage therapy for COVID-19 patients

The US Food and Drug Administration (FDA) has given the green light to the use of phage therapy for patients with severe COVID-19. In the severe course of COVID-19 with the adherence of secondary bacterial infection, patients have encountered antibiotic-resistant bacteria, most of which cause pneumonia and sepsis.

Adaptive Phage Therapeutics (APT), a U.S.-based company focused on clinical trials for the treatment of multidrug-resistant infections, is well known in the field of bacteriophage research. The new development, called PhageBank™, is based on a constantly replenished bank of bacteriophages, which provides an expanded range of therapeutic options. Initially, the technology was developed as part of the US Department of Defense's biological defense program, and later, in 2017, the company acquired international commercial rights. Adaptive Phage Therapeutics has partnered with the Mayo Clinic to launch mass production on a global scale. According to the FDA's New Drug Clinical Trial Authorization (IND), Adaptive Phage Therapeutics has started phage therapy for 30 critically ill COVID-19 patients when standard antibiotic treatment has not improved their condition.

To date, PhageBank™ has managed to cure 9 patients with a secondary bacterial infection caused by COVID-19. According to Sohail Rao, M.D., M.A., Ph.D., president and CEO of the DHR Health Institute for Research & Development, all patients were ventilated and had serious comorbidities. Phage therapy has helped reduce the number of bacteria of the genus Acinetobacter baumannii in patients with multidrug resistance. Adaptive Phage Therapeutics and its partners, including the Walter Reed Army Research Institute, have announced the possibility of using the therapy to fight infections caused by Staphylococcus aureus and Pseudomonas aeruginosa as part of clinical trials under the FDA's expanded access program.

On November 2, 2020, Adaptive Phage Therapeutics began using PhageBank™ as part of a clinical trial in Texas, where there was an outbreak of secondary infections caused by Acinetobacter baumannii bacteria. The first part of the program was aimed at developing a regulatory framework that will be applied to patients in serious condition to receive PhageBank™ therapy. The FDA approved this part, and Adaptive Phage Therapeutics and its partners acted as sponsors. Treatment is free of charge for patients, so the company has now begun the second part - the search for financial support. Greg Merrill, CEO and co-founder of Adaptive Phage Therapeutics, said that in order to continue research and provide medical care to the country's citizens, the company is counting on funding from a number of American government agencies and non-governmental organizations.

Source: Bacteriophage News