FDA Clears Expanded Access IND for PhageBank: COVID-19-Related Infections
Adaptive Phage Therapeutics (APT) announced the US Food and Drug Administration (FDA) clearance of the Expanded Access IND for PhageBank™ treatment for pneumonia or bacteremia/septicemia due to Acinetobacter baumannii, Pseudomonas aeruginosa or Staphylococcus aureus in COVID-19 patients.
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 since September 2020. Phage therapy apparently reduced the burden of multi-drug resistant Acinetobacter baumannii infection in these patients. Phages have demonstrated broad coverage having been screened against panels of over 200 multidrug resistant isolates created from WRAIR’s Multidrug Resistant Organism Repository and Surveillance Network (MRSN) repository.
The article states:
- “A significant increase in mortality has been seen in COVID-19 patients with antibiotic resistant bacterial infections.
- APT has made available therapeutic phage treatment to physicians in the Rio Grande Valley of Texas who are treating COVID-19 patients with secondary Carbapenem Resistant Acinetobacter baumannii (CRAB) on an emergency basis
- Now the FDA has granted APT an Expanded Access IND (EA IND) to facilitate the nationwide treatment of COVID-19 patients who develop bacterial infections
- APT and its partners are currently making therapy available to COVID-19 patients free for the public good and are seeking financial support from the government or non government organizations in order to enable continuing access to PhageBank™ treatment for these patients.”