Intralytix Receives FDA Clearance to Initiate Phase I / IIa Clinical Trials
Thursday, February 15, 2018
Intralytix, Inc. announced today that it received clearance from the Food and Drug Administration (FDA) to initiate Phase I / IIa clinical trials at Mount Sinai hospital in New York, N.Y.
In July of 2015, Intralytix entered into a collaboration agreement with Ferring Pharmaceuticals to develop a proprietary and well-defined set of bacteriophages specifically designed to treat inflammatory bowel diseases (IBD). The project aimed to test 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. Per Falk, Executive Vice President for R&D and Chief Science Officer of Ferring Pharmaceuticals, added "Bacteriophages offer a unique tool to gently fine-tune the gut microbiota by specifically targeting problem-causing bacteria. We are excited with the progress made by our partner Intralytix in obtaining IND approval for the phage preparation that targets AIEC – a pathogen increasingly implicated in the pathogenesis of Crohn's disease. We look forward to Intralytix initiating clinical trials with our colleagues at Mount Sinai hospital, to evaluate the safety and efficacy of this proprietary bacteriophage preparation in human volunteers."
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