U.S. FDA Approves IND for Bacteriophage Treatment of Patients with Resistant Infections of the Urinary Tract
Germantown, MD, USA (April 03, 2020) – Amarex Clinical Research, LLC announces that the U.S. Food and Drug Administration approved an IND application prepared and submitted by Amarex for their client Adaptive Phage Therapeutics, Inc. (APT). This allows APT to proceed with their Phase I/II study of a personalized bacteriophage therapeutic for the treatment of patients with multi-drug resistant (MDR) pathogenic bacteria and other complicated infections. This study helps APT expand their growing library of hundreds of bacteriophage (PhageBankTM) which kill the six highest priority MDR pathogenic bacteria.
Dr. Kazem Kazempour, President & CEO of Amarex stated, “This was a very challenging IND because bacteriophage is such a unique medical product. Many different phage will be treated as a single product, and maintaining the Drug Master File is complex as APT will be continually adding new phage. Another challenge was writing the clinical study protocol, with which Amarex assisted. It is a platform protocol with many potential cohorts structured in a decision tree format.”
“One of the difficult lessons we are all learning from the COVID-19 pandemic is that pharmaceuticals have to be able to rapidly adapt to new threats,” said Greg Merril, CEO of APT. “Our novel PhageBankTM approach allows for a rapid and adaptive approach to dealing with infectious disease. It’s the only way to combat these diseases and has required a new regulatory approach that Amarex has successfully helped us navigate.”
Amarex also prepared and submitted APT’s Type II Master File for Drug Product, and assisted APT with an Expanded Access use IND for several patients that had MDR infections. Amarex hopes to continue support of APT as they increase their phage bank and submit additional INDs for new therapeutic indications.
About Adaptive Phage Therapeutics, Inc.
Adaptive Phage Therapeutics, Inc. (APT) is a clinical-stage company founded to provide an effective therapeutic response to the global rise of multi-drug resistant (MDR) pathogenic bacteria. APT’s core asset is a large and continually expanding phage library (PhageBank™) deployed with a companion diagnostic to achieve rapid response and cost-effective therapy for otherwise recalcitrant bacterial infections. The technology was developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under the FDA emergency Investigational New Drug (eIND) allowance, APT has provided investigational PhageBank therapy to treat more than 20 critically ill patients in which standard-of-care antibiotics had failed. For more information, visit www.aphage.com.
About Amarex Clinical Research, LLC, an NSF International company
Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs (FDA Applications and meetings, Applications to International Health Authorities, GxP Compliance Audits), Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management, Medical Safety and Pharmacovigilance, and General Consulting. Amarex can take your product through the entire approval process, from creating the regulatory approval strategy, to conducting trials, to writing the marketing approval application. Join our growing list of clients with approved products. Amarex provides high quality and cost efficient services. For more information visit www.amarexus.com.
Book a meeting or send us a message to talk to one of our experts.