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FDA clears study of bacteriophages in IBD treatment
Biotech company Intralytix has obtained FDA clearance to begin a phase 1/2a study of bacteriophages specifically designed to treat inflammatory bowel disease, according to a press release.
Jean-Frederic Colombel, MD, principal investigator and professor of medicine at the Icahn School of Medicine at Mount Sinai Medical Center told Healio Gastroenterology and Liver Disease that they will take a closer look at bacteriophages that specifically target adherent-invasive Escherichia coli (AIEC), a strain of the bacteria that is regularly found in the mucosa of patients with Crohn’s disease (CD).
“Several therapeutic strategies targeting AIEC colonization have been proposed to slow or even halt the natural course of CD,” Colombel said. “Manipulation of the patient’s microbiota through antibiotic treatment, fecal transplantation, nutritional interventions or the administration of pre/probiotics could be used either alone or in combination with immunotherapy, to induce the remission of active disease or as a postoperative treatment to prevent relapse. However, the results obtained to date have been inconsistent.”
Intralytix partnered with Ferring Pharmaceuticals in 2015 to develop a set of bacteriophages to treat inflammatory bowel disease.
In the phase 1/2a trial, the researchers will evaluate the ability of specific bacteriophages to reduce colonization with AIEC in patients with CD. Participants will take the bacteriophage twice a day for 15 days, and investigators will follow them for 6 months, according to Colombel.
The investigators will assess the safety of the bacteriophages as a primary objective, as well as their efficacy compared with a placebo.
“This is one of the first full-blown [investigational new drug applications] approved for phages by the FDA, and the first ever IND approved for targeting [AIEC] in patients.” Alexander Sulakvelidze, MD, executive vice president and chief scientific officer of Intralytix said in the press release. “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." – by Alex Young
Disclosures: Sulakvelidze is employed by Intralytix. Colombel reports financial ties to Ferring Pharmaceuticals.