Clinical Trials

Date: 2018-02-15

Type of information: Clinical trial authorisation

phase: 1-2a

Announcement: clinical trial authorization

Company: Intralytix (USA - MA)

Product: set of bacteriophages specifically

Action mechanism: bacteriophage

Disease: inflammatory bowel disease

Therapeutic area: Gastrointestinal diseases - Digestive diseases

Country:

Trial details:

Latest news:

• On February 15, 2018, Intralytix announced that it received clearance from the FDA to initiate Phase I / IIa clinical trials at Mount Sinai hospital in New York, NY. In July of 2015, Intralytix entered into a collaboration agreement 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.
Dr. Alexander Sulakvelidze, Executive Vice President and Chief Scientific Officer of Intralytix commented: "This is a major milestone in the history of our company, and in the phage therapy field in general. This is one of the first full-blown INDs approved for phages by the FDA, and the first ever IND approved for targeting adhesive invasive E. coli (AIEC) in patients. 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."