Intralytix Obtains FDA Clearance for Investigational New Drug Application for Phase 1/2a Clinical Trials for Phage Preparation Targeting Vancomycin-Resistant Enterococci (VRE) BioBuzz
Intralytix Obtains FDA Clearance for Investigational New Drug Application for Phase 1/2a Clinical Trials for Phage Preparation Targeting Vancomycin-Resistant Enterococci (VRE)
Columbia, Maryland, USA. – May 9, 2022 – Intralytix, Inc. today announced that it has received clearance from the United States Food and Drug Administration (FDA) for an investigational new drug (IND) application for its product VRELysin™, a bacteriophage preparation intended to manage colonization of vancomycin-resistant bacteria. Enterococcus (ERV) in the human intestine. Under this IND, ongoing, randomized, double-blind Phase 1/2a clinical trials will be conducted to evaluate the safety and efficacy of VRELysin™ in the decolonization of VRE in the gastrointestinal tract. Dr. Alexander Sulakvelidze, President and CEO of Intralytix, said, “This FDA-approved IND is an exciting step in the advancement of phage therapy in the United States. This study will address an important public health issue and the resulting product should help reduce serious bacterial infections. infections caused by VRE.
The trial will be carried out in collaboration with Ferring Pharmaceuticals. “We are committed to advancing microbiome research and developing a new generation of drugs to treat various conditions related to the gut microbiome,” remarked Dr. Kristin Wannerberger, Director of R&D Alliance Management, Ferring Pharmaceuticals. “We are very pleased with this latest step in the process of advancing phage therapy.”
Dr. Jennifer Schwartz, Vice President of Clinical Development at Intralytix, added, “Enterococci are normally a natural part of a person’s gut microbiome. However, with increasing antibiotic resistance, VRE has become a major cause of infections acquired in healthcare and long-term care settings, which can cause life-threatening infections, especially in immunocompromised people. . These phase 1/2a trials will advance the development of a safe and effective, non-antibiotic modality to manage VRE colonization in the gastrointestinal tract, which is a major risk factor for VRE-associated infections. Dr. Sulakvelidze concluded, “Intralytix continues to be the world leader in phage therapy and biocontrol applications. This IND approval is another important step in improving our development programs for bacteriophage preparations to modulate the human microbiome for various health benefits and to manage bacterial diseases, including those caused by bacterial pathogens. multiresistant. The contents of this press release are the sole responsibility of Intralytix and do not necessarily represent the official views of the FDA.
About Intralytix Inc.
Intralytix, Inc. is a privately held company headquartered in Columbia, Maryland. The Company is focused on using its bacteriophage core technology platform to develop and commercialize innovative bacteriophage-based products for food safety, animal health, human therapeutics, oral care, cosmetics and dietary supplement/probiotic applications.
Intralytix was the first company in the world to receive FDA approval for a bacteriophage product for food safety applications. The company currently has the world’s largest portfolio of FDA-approved bacteriophage products in commercial markets and is the largest producer of bacteriophage preparations for food safety applications globally. Intralytix is currently a sponsor (and IND holder) of two clinical trials, at: (1) Mount Sinai Hospital in New York (https://clinicaltrials.gov/ct2/show/NCT03808103?term=Intralytix&rank=1), and (2) University of Maryland Medical School Baltimore Vaccine Development Center (https://clinicaltrials.gov/ct2/show/NCT05182749?term=NCT05182749&draw=2&rank=1). The Company also has several additional human bacteriophage therapeutic products in various stages of development, with additional clinical trials expected to begin within the next 12 to 18 months. To learn more, please visit www.intralytix.com or contact Dr. Alexander Sulakvelidze (410-625-2533, [email protected]).
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