Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company dedicated to advancing therapies that address the global rise of multi-drug resistant infections, announced today that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for PhageBank™ phage therapy for the treatment of Diabetic Foot Osteomyelitis (DFO).
“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. “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.”
DFO is the result of soft tissue infections in diabetic patients that spread into bone. Based on research by The Center for Biosimilars, someone is diagnosed with diabetes every 17 seconds, and 230 people with diabetes will suffer an amputation every day in the United States. Globally, it is estimated that a leg is amputated every 30 seconds, with 85% of these amputations resulting from a diabetic foot ulcer(1). With more than 1.5 million patients worldwide being diagnosed with diabetes each year, amputations as a result of diabetes comprise a significant portion of non-trauma related amputations. The American Diabetes Association estimates that 20% of patients with diabetic foot infections, and more than 60% of those with severe infections, have underlying osteomyelitis, placing patients at significantly higher risk of amputation(2).
APT’s PhageBank™ is a precision-matched phage therapy that specifically targets bacterial pathogen(s) identified as the cause of patient infection. PhageBank™ comprises a library of purified phages covering a broad spectrum of bacterial species. APT has also developed a proprietary PhageBank Susceptibility Test™ (PST) to rapidly identify the specific phage(s) required to provide precision therapy of bacterial infections.
The Defense Health Agency, a branch of the Department of Defense (DoD), is an integrated Combat Support Agency that enables the military’s medical services to provide a ready medical force in any situation. In 2019 the DoD awarded APT a $14 million contract for advanced development of its PhageBank™ platform. The award is funded by the Defense Health Agency and the Naval Medical Research Center.
APT is advancing clinical trials for all three initial PhageBank™ target indications: in Diabetic Foot Osteomyelitis (DFO), Prosthetic Joint Infections (PJI), and Urinary Tract Infections (UTI). APT’s Phase I/II PhageBank™ DFO trial is planned as a randomized, open-label, parallel-group, controlled study to evaluate the safety and efficacy of PhageBank™ therapy in conjunction with standard of care versus standard of care. APT plans to initiate the DFO clinical trial in 2021, with a first interim data analysis expected in 2022.
Adaptive Phage Therapeutics, Inc.
Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies addressing multi-drug resistant infections. Prior antimicrobial therapeutic approaches have been “fixed,” while pathogens continue to evolve resistance to each of those therapeutics, causing those drug products to become rapidly less effective in commercial use as antimicrobial resistance (AMR) increases over time. APT’s PhageBank™ approach leverages an ever-expanding library of bacteriophage (phage) that collectively provide evergreen broad spectrum and polymicrobial coverage. PhageBank™ phages are matched through a proprietary phage susceptibility assay that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale. APT’s technology was originally developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under FDA emergency Investigational New Drug allowance, APT has provided investigational PhageBank™ therapy to treat more than 40 critically ill patients in which standard-of-care antibiotics had failed.