FDA Clears Clinical Studies for New Bacteriophage Treatment for Crohn’s Disease

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FDA Clears Clinical Studies for New Bacteriophage Treatment for Crohn’s Disease

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We are one step closer to seeing a new kind of treatment to combat inflammatory bowel disease (IBD). On February 15, the U.S. Food and Drug Administration (FDA) gave its seal of approval to a new Phase 1/2 clinical trial in humans at Mount Sinai hospital in New York City to test a new bacteriophage treatment for Crohn’s disease.

Why is this important? It would be one of the first investigational new drug (IND) applications ever approved for bacteriophages by the FDA, and is also the first approved to target what is known as adhesive invasive E. coli (AIEC), a strain of bacteria that can be found in people who have Crohn’s.

A bacteriophage, or a phage, is a virus that can be deployed to target and eradicate specific harmful bacteria, like AIEC. Phages are alternatives to antibiotics, which have become a hot-button issue in the medical community due to the dangers of antibiotic resistance. A renewed emphasis on phages may lead to a path forward beyond antibiotics.

“The importance of this approval is not just this clinical trial — although that’s important,” says Dr. Alexander Sulakvelidze, Ph.D, the executive vice-president and chief scientist at Intralytix, Inc., which developed these IBD-attacking phages with Ferring Pharmaceuticals. “It’s an important step in phage therapy, in general. There are very serious public health implications beyond Crohn’s disease. It could be huge.”

The road leading to the FDA announcement began in 2015 when the two companies first started to collaborate on developing the phage treatment for IBD. Sulakvelidze says that the first clinical trials will start later this year and will probably take at least a year and a half, to carry out. There is a chance that the trial could take longer.

This upcoming research factors into the growing interest in the study of the microbiome, or the communities of microbes in everyone’s body that play vital roles in our overall health. As more and more emphasis is placed on our microbial health, Sulakvelidze says we will move toward more targeted solutions for treating conditions like Crohn’s.

Read on: FDA Clears Clinical Studies for New Bacteriophage Treatment for Crohn’s Disease | Everyday Health

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