Intralytix Granted Clearance by the FDA for an Investigational New Drug Application for Phase 1/2a Clinical Trials for Vancomycin Resistant Enterococci (VRE)-targeting Phage Preparation

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Intralytix, Inc. announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for its product VRELysin™, a bacteriophage preparation to manage colonization of vancomycin resistant Enterococcus (VRE) in the human gut. Under this IND, continuous, randomized, double-blind Phase 1/2a clinical trials will be performed to assess the safety and efficacy of VRELysin™ in decolonizing VRE in the gastrointestinal tract. Dr. Alexander Sulakvelidze, President and CEO of Intralytix, commented “This IND approved by the FDA is an exciting step in advancing phage therapy in the U.S. This study will address a significant public health issue and the resulting product is expected to help reduce serious bacterial infections caused by VRE.”

Intralytix Receives SBIR Grant to Develop Phage Preparation for Reducing Vibrio parahaemolyticus Contamination of Foods

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Intralytix, Inc. announced today that it has received a Phase I Small Business Innovation Research (SBIR) grant from the National Institute of Food and Agriculture (NIFA), an agency of the U.S. Department of Agriculture (USDA), for the development of a phage biocontrol solution for Vibrio parahaemolyticus
in various food products.

Is Maryland Becoming a Hub for Bacteriophage Technologies?

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The Bacteriophage (Phage) Therapy (PT) market is growing rapidly in the U.S. The rise of antibiotic resistant bacteria and multidrug-resistant bacteria (MDRs) across the globe has increased the value and industry acceptance of a phage approach, which can help combat bacteria that cannot be effectively treated by antibiotics. What’s more, the phage modality is a great fit for targeted personalized medicine approaches.

Intralytix Opens New HQ in Columbia, Maryland for Phage Research and Manufacturing Facility

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From left to right:

– Per Falk, President & CSO, Ferring Pharmaceuticals
– John Woloszyn, Founder, President & CEO, Intralytix, Inc.
– Calvin Ball, County Executive, Howard County, Maryland
– Alexander Sulakvelidze, Founder, EVP & CSO, Intralytix, Inc.
– Antoine Baule, CEO, Lesaffre Compagnie