Columbia, Maryland – February 22, 2023 – Intralytix, Inc. today announced the launch of a Phase 1/2a clinical trial to assess the safety and efficacy of Intralytix phage therapy product ShigActive™ to prevent or reduce the severity of Shigella infections.
Dr. Alexander "Sandro" Sulakvelidze, President & CEO of Intralytix.Recruitment for the continuous Phase 1/2a trial began at the University of Maryland's School of Medicine (UMSOM) in Baltimore. The phage therapy trial is being conducted by researchers in UMSOM's Center for Vaccine Development and Global Health (CVD) led by Dr. Wilbur Chen, Professor of Medicine and Chief of Adult Clinical Studies. Shigella is an important human bacterial pathogen responsible for approximately 125 million worldwide cases of shigellosis and 14,000 deaths annually, the majority occurring in children under the age of five. Dr. Alexander Sulakvelidze, President and CEO of Intralytix, commented "This clinical trial is an exciting step forward towards our Company developing safe and effective phage therapy treatment and prevention approaches for diarrheal diseases, such as shigellosis. The resulting product is expected to have very significant positive public health impact worldwide."
Dr. Wilbur Chen, MD, MS, FIDSA, FACP, Professor of Medicine at the University of Maryland School of MedicineDr. Wilbur Chen, the Principal Investigator at the CVD added, "I am excited to be involved with this study, which is intended to show that bacteriophages can be safe and effective treatment strategies for antimicrobial resistant infections."
This research is funded by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH, project number 5U01AI148054-03 (https://reporter.nih.gov/search/WTSFRIdfjEisvOA5iIEnGw/project-details/10397590).
About Intralytix Inc.
Intralytix, Inc. is a privately held company headquartered in Columbia, Maryland. The Company is focused on using its core bacteriophage technology platform to improve human health through the development and commercialization of innovative products for food safety, animal health, human therapeutics, oral care, cosmetic, and dietary supplements/probiotic applications. Intralytix was the first company in the world to receive FDA-approval for a bacteriophage-based product for food safety applications. The Company currently has the world's largest portfolio of FDA-approved bacteriophage-based products on commercial markets and is the largest producer of FDA-approved bacteriophage preparations for food safety applications worldwide. Intralytix is currently the sponsor of (and holder for) three FDA-approved Investigational New Drugs (INDs) for randomized, controlled clinical trials: (1) at the Mount Sinai Hospital in New York (NCT03808103; https://clinicaltrials.gov/ct2/show/NCT03808103?term=Intralytix&rank=1); (2) at the Center for Vaccine Development at the University of Maryland School of Medicine in Baltimore (NCT05182749; https://clinicaltrials.gov/ct2/show/NCT05182749?term=NCT05182749&draw=2&rank=1); and (3) to target vancomycin-resistant Enterococci (VRE) in the gastrointestinal tract (NCT05715619; https://clinicaltrials.gov/ct2/show/NCT05715619?term=intralytix&draw=2&rank=2). The Company also has several additional human therapeutic bacteriophage products in various stages of development. To learn more, please visit www.intralytix.com or contact Dr. Alexander Sulakvelidze (410-625-2533, firstname.lastname@example.org).