FDA Clears Clinical Studies for New Bacteriophage Treatment for Crohn’s Disease
The research could pave the way for bacteriophage treatments for other diseases.
February 28, 2018
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.
This could potentially make a big difference in the treatment of IBD, which affects roughly three million people according to the Centers for Disease Control and Prevention (CDC).
“If AIEC turns out to be a disease modifier in Crohn’s disease, therapeutic strategies targeting its colonization could potentially halt or slow the natural course of Crohn’s disease,” says Dr. Jean-Frédéric Colombel, MD, director of the Susan and Leonard Feinstein IBD Clinical Center at Mount Sinai, who will lead the clinical trial.
Sulakvelidze and Colombel stress that AIEC is not a cause of Crohn’s, but finding a way to combat it could play a big role in offering more effective treatment for the condition. Colombel adds that beyond phage therapy, the harmful bacteria in a person’s body can also be manipulated through nutritional interventions, antibiotic treatments, prebioticsand postbiotics, and fecal transplants.
Phage therapy like this, has had an interesting history. Sulakvelidze says that since the first phages were discovered in 1917, phages took a back seat to antibiotics in the United States, while they continued to stand as a major player in fighting harmful bacteria in Europe. He says the rise of antibiotic-resistant bacteria as well as a renewed appreciation for the fact that not all bacteria is necessarily harmful for us, has led to its greater prominence in U.S. research.
“Crohn’s disease is such a complex disease — it’s not just a simple bacterial infection,” he adds. “This treatment will not completely eradicate it, but our hope is that we can reduce the incidence of AIEC. Crohn’s is a huge problem everywhere. It has an economic impact of about $5 billion a year. This phage treatment will hopefully be very effective in fighting it.”