FDA OKs Clinical Trial to Test Bacteriophage-Based Treatment for Crohn’s

FDA OKs Clinical Trial to Test Bacteriophage-Based Treatment for Crohn’s
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The U.S. Food and Drug Administration (FDA) recently cleared a Phase 1/2a clinical trial to study a set of bacteriophages designed to treat inflammatory bowel diseases (IBDs), specifically Crohn’s disease.

The bacteriophages were developed as part of a July 2015 collaboration agreement between Intralytix and Ferring Pharmaceuticals. Together with French researchers from the University of Lille and Auvergne, the companies focused on studying a specific strain of the bacteria Escherichia coli (AIEC), which has been linked to Crohn’s disease.

Bacteriophages are virus-like organisms that have naturally evolved to target and eliminate specific bacteria. They show significant potential as an alternative to antibiotics in treating bacterial infections without affecting good bacteria, like those in the normal gut flora. They also present an opportunity to improve the human microbiome (the collective name for the genes that make up microorganisms — microbes, bacteria, virus and fungi — in the body) and to address the growing issue of antibiotic resistance, which is an increasingly serious threat to global public health and a key focus of the collaboration.

Researchers developed a new therapy based on bacteriophages that specifically targets the various AIEC bacteria strains that have been found in patients with Crohn’s disease. The clinical trial, which will be conducted at Mount Sinai Hospital in New York City, will test the feasibility and effectiveness of the therapy in human patients.

“AIEC have been implicated in the pathogenesis [development] of Crohn’s disease. Bacteriophages may offer a much-needed approach for specifically targeting AIEC in the human gastrointestinal tract …  reducing the risk of progression of Crohn’s disease. If the approach shows efficacy in the planned clinical trials in our hospital, it will enhance and expedite product development and could ultimately benefit hundreds of thousands of people suffering from Crohn’s disease,” said Jean-Frederic Colombel, MD, principal investigator of this clinical trial, in a press release.

“Bacteriophages offer a unique tool to gently fine-tune the gut microbiota by specifically targeting problem-causing bacteria. 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,” said Per Falk, MD, PhD, chief scientific officer of Ferring.

Intralytix is the only company worldwide to receive FDA approval for a phage-based product for food safety applications. The company holds several bacteriophage technology-related patents, including two patents in the U.S. on the use of bacteriophages for fine-tuning human or animal microbiome by using phages to reduce or eliminate bacterial colonization.

Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Técnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.
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Margarida graduated with a BS in Health Sciences from the University of Lisbon and a MSc in Biotechnology from Instituto Superior Técnico (IST-UL). She worked as a molecular biologist research associate at a Cambridge UK-based biotech company that discovers and develops therapeutic, fully human monoclonal antibodies.
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