FDA Accepts Investigational New Drug Application for Diabetic Foot Osteomyelitis Treatment
By Adam Hochron
March 15, 2021
The FDA has accepted an Investigational New Drug application for a phage therapy to treat diabetic foot osteomyelitis (DFO).
A release from the manufacturer describes the novel PhageBank as a “precision-matched phage therapy that specifically targets bacterial pathogen(s) identified as the cause of patient infection.” The treatment includes several purified phages which can address a variety of bacterial species. Development of the treatment was made possible due in part to a $14 million award from the Defense Health Agency and the Naval Medical Research Center.
“Advancing PhageBank therapy targeting diabetic foot osteomyelitis is a critical step in providing viable treatment options to diabetic patients facing significant morbidities, including potential amputation,” said Greg Merril, CEO, and co-founder of Adaptive Phage Therapeutics, in the release. “Today’s announcement marks the third successful IND application by APT in the last year, further validating the potential of our novel PhageBank platform to more effectively treat a range of drug-resistant bacterial infections and enabling APT to rapidly progress towards multiple clinical inflection points.”
The release from the manufacturer noted that the company is currently developing clinical trials examining the PhageBank as a treatment for DFO, prosthetic joint injections, and urinary tract infections. The DFO trial is expected to study PhageBank in conjunction with standard of care versus the standard of care alone. The trial is expected to start this year, with a first interim data analysis expected next year.