Intralytix Launches Phase 1/2a Phage Therapy Trial of Its VRELysin™ Phage Preparation, to Assess Safety and Efficacy in Healthy and VRE-Colonized Subjects

Columbia, Maryland - September 12, 2023 - Intralytix, Inc. today announced the launch of a Phase 1/2a clinical trial to assess the safety and efficacy of its phage therapy product VRELysin™ in significantly reducing or eliminating vancomycin-resistant enterococci (VRE) levels in the
Dr. Alexander "Sandro" Sulakvelidze, President & CEO of Intralytix. human gastrointestinal tract. The trial is being performed at the University of Pittsburgh Medical Center (UPMC) in Pittsburgh, Pennsylvania, USA. Dr. Alexander Sulakvelidze, President and CEO of Intralytix, commented "This clinical trial is another exciting step towards our Company developing yet another safe and effective phage therapy product for managing multidrug-resistant bacterial infections, such as infections caused by VRE. The VRE infections are particularly dangerous for hospitalized patients, especially those in intensive care units, as they are very difficult to treat because of their resistance to commonly available antibiotics.” Dr. Sulakvelidze concluded “We expect VRELysin™ to significantly reduce or eliminate VRE in hospitalized patients which in turn will reduce the risk of serious VRE infections that could potentially be fatal, as well as to lessen the nosocomial spread of VRE in ICU units, nursing homes, etc. Therefore, the resulting product is expected to have very significant positive implications not just for individual patients but also on a more general level by helping reduce the risk of hospital acquired VRE infections."

VRELysin offers a potentially very powerful new tool for clinicians to manage VRE colonization in the patients. While VRE infections are not very common - only about 20,000 people in the United States become infected with it each year – they are very difficult to treat resulting in almost 10% of those infected people dying. If the trial shows promise, VRELysin can provide a much-needed non-antibiotic-based treatment modality for managing multi-drug resistant VRE strains – a modality which is critically needed, especially for patients for whom these infections are life threatening, such as transplant patients.

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, veterinary applications, 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); (2) at the Center for Vaccine Development at the University of Maryland School of Medicine in Baltimore (NCT05182749); and (3) to target vancomycin-resistant Enterococci (VRE) in the gastrointestinal tract (NCT05715619). To learn more, please visit www.intralytix.com or contact Dr. Alexander Sulakvelidze (410-625-2533, asulakvelidze@intralytix.com).