Adaptive Phage Therapeutics Announces FDA Clearance of IND Application for PhageBank™ for the Treatment of Prosthetic Joint Infections
- Phase 1/2 trial to be conducted at Mayo Clinic in Rochester, Minnesota, starting Q2 2021 –
GAITHERSBURG, Md.--(BUSINESS WIRE)--Adaptive Phage Therapeutics (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat the global rise of bacterial and viral infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PhageBank™ phage therapy for the treatment of prosthetic joint infections (PJI). With this IND clearance, APT plans to initiate a Phase 1/2 trial of PhageBank™ in PJI in the first half of 2021 in collaboration with Mayo Clinic.
“This FDA clearance of the PhageBank™ IND in PJI represents a major milestone for APT, underscoring the agency’s support for our technology, and validating the dynamic and durable approach we are taking to applying phage therapy in an expanding range of indications,” said Greg Merril, CEO and co-founder, Adaptive Phage Therapeutics. “In combination with our earlier IND clearance, in 2020, for PhageBank™ in urinary tract infections (UTI), this IND in PJI is another important step in the execution of APT’s PhageBank™ development program. APT now expects to generate a series of UTI and PJI interim clinical data readouts in 2021 and 2022.”
“We are excited to collaborate with Adaptive Phage Therapeutics in this PJI clinical study of PhageBank™, and to assess the potential of phage therapy to help people with these infections and save lives,” said Gina Suh, M.D., infectious diseases specialist and one of the experts at Mayo Clinic leading the research collaboration with APT. “Phage therapy represents a potentially game-changing new treatment option for PJI and other multi-drug resistant or biofilm-mediated bacterial infections, where current patient outcomes can include loss of limb or even life.”
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 wide spectrum of specific bacterial species. APT has also developed a proprietary Host Range Quick Test (HRQT) to rapidly identify the specific phage therapy needed to lyse bacterial infections.
PJI is a serious complication of joint replacement surgery that can occur following implantation. From 2001 to 2009 the annual incidence of PJI in the United States alone, increased from 1.99% to 2.18% for hip arthroplasties and from 2.05% to 2.18% for knee arthroplasties. Currently, surgical intervention in combination with antibiotics is the standard of care for such infections, with PJI’s annual cost to the U.S. healthcare system estimated to be more than $1.6 billion*. Based on an international survey of hospital payors and doctors, conducted by Triangle Insights Group, it is estimated that APT’s PhageBank™ treatment of PJI represents a commercial market of more than $900 million per year.
APT’s Phase 1/2 PhageBank™ PJI trial is planned as a randomized, open-label, parallel-group, controlled study to evaluate the safety and surgery-sparing effect of PhageBank™ phage therapy in conjunction with antibiotics for patients with culture-proven chronic prosthetic joint infection who are candidates for two stage exchange arthroplasty. APT plans to initiate this clinical trial in the first half of 2021, with a first interim data analysis expected in the first quarter of 2022.
Mayo Clinic and Dr. Suh have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.
*Kurtz SM, Lau E, Watson H, Schmier JK, Parvizi J. Economic burden of periprosthetic joint infection in the United States. J Arthroplasty. 2012 Sep;27(8 Suppl):61-5.e1. doi: 10.1016/j.arth.2012.02.022. Epub 2012 May 2. PMID: 22554729.
Adaptive Phage Therapeutics, Inc.
Adaptive Phage Therapeutics (APT) is a clinical-stage biotechnology company advancing therapies to treat antimicrobial resistant (AMR) infections. AMR is accelerating as a crisis for global health, caused by constant and relentless evolution of bacteria, which has driven traditional antibiotics to fail therapeutically and commercially. APT’s PhageBank™ was specifically designed to overcome the challenge of ever-evolving AMR pathogens by treating them with an ever-expanding library of bacteriophage (phage) that collectively provide “evergreen” broad spectrum and polymicrobial coverage. As a result, APT believes that PhageBank™ is very well positioned for long-term clinical and commercial viability. PhageBank™ phages are precisely matched to AMR bacteria 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, from which APT acquired 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, please visit http://www.aphage.com.
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