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news.Adaptive Phage Therapeutics (APT) said that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for the clinical development of PhageBank, a personalized bacteriophage therapeutic for the treatment of MDR and complicated bacterial infections.
The US FDA’s Center for Drug Evaluation and Research. (Credit: The U.S. Food and Drug Administration/Wikipedia.org)
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The Phase 1/2 trial represents the first study of an expanding phage library under FDA allowance for a multi-site study of intravenous administration and/or bladder instillation of phage therapy. Beginning in Q2, APT will enroll patients at up to three clinical sites for the evaluation of PhageBank for the treatment of complicated and chronic recurrent urinary tract infections (UTIs).
“FDA clearance of our IND is a significant milestone toward our goal of advancing a durable cure to MDR and complicated infections,” said Greg Merril, Chief Executive Officer and co-founder of APT. “Unlike antibiotics, which offer static therapies for dynamic pathogens and become obsolete from emerging resistance resulting in market-compressing antibiotic stewardship, PhageBank will be the first antimicrobial to increase in spectrum with use – obviating obsolesensce and the need for stewardship. From a business model point-of-view, PhageBank is the anti-antibiotic.”
PhageBank will be evaluated in patients with complicated and chronic recurrent urinary tract infections. The trial will be conducted at the James J. Peters VA Medical Center in Bronx, New York, and two other sites in the U.S. The trial is supported in part by the US Department of Defense (DoD) under a $10.2 million advanced development contract. The DoD contract award is designated to make PhageBank phage therapy available to treat MDR and complicated infections.
About the BEUTIFL (“Bacteriophage Evaluation in UTI First Look” ) Clinical Trial
According to Cmdr. Christopher Duplessis, MD a researcher at Naval Medical Research Center (NMRC), “As antibiotics become less effective, the need for alternative options becomes a matter of significant public health importance,” he said. “Phage therapy was initially developed by NMRC’s Biological Defense Research Directorate (BDRD), in response to MDR and complicated bacterial infections among service members. Recent technological advances, as well as the emerging threat of antibiotic resistance, create a timely opportunity for us to support its broader use. We are proud of the DoD’s role in driving the initial development of this potential therapy and supporting its regulatory pathway to potentially benefit our warfighters and all Americans.”
Source: Company Press Release
