Bacteriophage technology company Intralytix Inc said on Thursday that it has passed the Food and Drug Administration's (FDA) clearance to initiate Phase I / IIa bacteriophages clinical trials at Mount Sinai hospital in New York, N.Y.

Previously in 2015, Intralytix partnered 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.

Bacteriophages offer a unique tool to gently fine-tune the gut microbiota by specifically targeting problem-causing bacteria. Intralytix has obtained IND approval for the phage preparation that targets AIEC – a pathogen increasingly implicated in the pathogenesis of Crohn's disease, according to Dr Per Falk, EVP for R&D and CSO of Ferring Pharmaceuticals.

In conjunction, Intralytix will initiate clinical trials with Ferring's colleagues at Mount Sinai hospital, to evaluate the safety and efficacy of this proprietary bacteriophage preparation in human volunteers, added Dr Falk.

The Mount Sinai Health System is New York City's largest integrated delivery system encompassing seven hospital campuses, a leading medical school and a vast network of ambulatory practices throughout the greater New York region.