FDA ALLOWS PHAGE THERAPY FOR COVID19 PATIENTS
FDA allows phage therapy for COVID19 patients
The FDA has given Adaptive Phage Therapeutics a green light to Expanded Access IND to use of phage therapy for COVID19 patients who are in a critical state. Bacterial infections as a result of secondary infection due to COVID19 has left patients facing the battle against antibiotic resistance. The majority of bacteria are those that cause pneumonia and sepsis.
Adaptive Phage Therapeutics (APT) is a clinical-stage company focusing on therapies to battle against multi-drug resistant infections and is well known in the community of phages. The company’s PhageBank™ approach leverages a growing library of bacteriophages which helps create a growing spectrum of therapeutic possibilities. The technology was originally developed by the biodefense program of the U.S. Department of Defense and later, in 2017, acquired worldwide commercial rights. Adaptive Phage Therapeutics has teamed up with Mayo Clinic Laboratories in order to commercialize on a global scope. Under the FDA emergency Investigational New Drug allowance, Adaptive Phage Therapeutics has been allowed to administer their phage therapy to 30 COVID19 critical patients, in those cases, the standard care of antibiotics have failed.
Phage therapy for COVID19 patients
PhageBank™ therapy has so far been able to treat 9 patients that presented secondary bacterial infection due to COVID19. Sohail Rao, M.D., M.A., D.Phil, President & CEO, DHR Health Institute for Research & Development commented that all patients had been ventilated and had significant co-morbidities. Phage therapy helped reduce with multi-drug resistant Acinetobacter baumannii infection that was present in the patients. Adaptive Phage Therapeutics and their partners including the Walter Reed Army Institute of Research are in the capability to address infections caused by Staphylococcus aureus and Pseudomonas aeruginosa that are covered under the Expanded Access IND scope.
Texas had experienced an outbreak of secondary infections due to Acinetobacter baumannii. On 2nd November 2020, Adaptive Phage Therapeutics deployed its investigation PhageBank™ therapy to help deal with the crisis. The first strategy was to deal with the outbreak by outlining the regulatory process to be used on critical patients to receive the PhageBank™ therapy. This was approved by the FDA and was covered by Adaptive Phage Therapeutics and their partners. The treatment is free for patients, and thus the company is now looking at the second part of the strategy, financial aid. Greg Merril, Adaptive Phage Therapeutics’ CEO and co-founder said that the company is seeking funding from a number of U.S. government agencies and non-governmental bodies, to have the ability to continue and meet the medical needs of the country.