Intralytix sought FDA clearance to begin Phase I/IIa Clinical Trials for bacteriophages
Intralytix proclaimed having sought Food and Drug Administration’s clearance to commence Phase I/IIa Clinical Trials at Mount Sinai hospital in New York. Dating back to July,2015, Intralytix ventured into a collaboration agreement with Ferring Pharmaceuticals to curate a proprietary and well-defined set of bacteriophages specifically designed to treat inflammatory bowel diseases (IBD). The project aimed to assess the feasibility and efficacy of the bacteriophages in controlled human clinical trials.
Dr. Alexander Sulakvelidze, Executive Vice President and Chief Scientific Officer of Intralytix commented: “This is a major milestone in the history of our company, and in the phage therapy field in general. This is one of the first full-blown INDs approved for phages by the FDA, and the first ever IND approved for targeting adhesive invasive E. coli (AIEC) in patients. This approval paves the way for an important clinical study, and also shows that Intralytix continues to demonstrate our leadership in successfully obtaining regulatory approvals and commercializing various bacteriophage products.”
Dr. Jean-Frederic Colombel, MD, Professor of Medicine (Gastroenterology) at the Icahn School of Medicine at Mount Sinai and Director of the Leona M. and Harry B. Helmsley Charitable Trust Inflammatory Bowel Disease Center at the Mount Sinai Medical Center, will serve as the Principal Investigator of this clinical trial. Dr. Colombel commented: “AIEC have been implicated in the pathogenesis of Crohn’s disease. Bacteriophages may offer a much-needed approach for specifically targeting AIEC in the human gastrointestinal tract thereby reducing the risk of progression of Crohn’s disease.”