Adaptive Phage Therapeutics Initiates Phase 1/2 Trial of PhageBank™ in Urinary Tract Infections
June 03, 2021 08:00 AM Eastern Daylight Time
GAITHERSBURG, Md.–(BUSINESS WIRE)–Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced that the first patient has been dosed in a Phase 1/2 study of bacteriophage therapy (PhageBank™) to evaluate the safety, tolerability, and efficacy of targeted, personalized, bacteriophage (“phage”) treatments in patients with urinary tract infection (UTI).
This multi-center clinical trial represents the first study of an expanding phage library for intravenous administration and/or bladder instillation of phage therapy. PhageBank™ is APT’s continually expanding phage library that functions as an integrated logistics platform to dispense phage on demand. The phage distributed are selected via a PhageBank Susceptibility Test™ (PST) that is being advanced and commercialized by APT in collaboration with Mayo Clinic Laboratories. The PST enables rapid, automated identification of individual phage to be included in patient-specific therapy to treat bacterial infections.
“I’m delighted to announce the initiation of APT’s first PhageBank™ clinical trial, which is being funded in part by the U.S. Department of Defense through an advanced development contract intended to accelerate clinical progression of PhageBank™ therapy to more effectively treat multidrug-resistant infections,” said Greg Merril, CEO and co-founder, Adaptive Phage Therapeutics. “This Phase 1/2 UTI trial is the first of several initial indications in which APT plans to study PhageBank™, following the success achieved in PhageBank™ treatment of more than 40 emergency INDs for individual patients. APT recently received IND clearance for PhageBank™ treatment of prosthetic joint infection (PJI) and diabetic foot osteomyelitis (DFO), and plans to initiate clinical studies for these two indications. Initial data readouts in PJI and DFO are expected in 2022.”
The UTI Phase 1/2 study, evaluating the safety and efficacy of bacteriophage therapy, is being conducted at the James J. Peters VA Medical Center in Bronx, New York, as well as multiple other U.S. clinical study sites, and is supported in part by the U.S. Department of Defense (DoD) under a $14.2 million advanced development contract.
This interventional, randomized, placebo-controlled, open label study is designed to enroll approximately 156 patients. Patients enrolled have urinary tract infections due to either E. coli or K. pneumoniae. The trial will use pre-specified criteria to determine phage regimens for evaluation. Results from an initial cohort will be used to confirm or modify the phage dosing regimen and route, before progressing to patients with symptomatic infection at a higher risk of recurrence. Patients will be followed for bacterial clearance or recurrence of urinary tract infection. Clinical results from this trial are expected to lead to regulatory approval to advance directly into pivotal trials for chronic and recurrent urinary tract infections.
Adaptive Phage Therapeutics, Inc.
Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies to treat 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.
For more information, visit http://www.aphage.com.
Adaptive Phage Therapeutics
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