On February 15, 2018, the U.S. Food and Drug Administration (FDA) approved a Phase 1/2 clinical trial of a new bacteriophage-based drug for the treatment of Crohn's disease, an inflammatory bowel disease. This is one of the first FDA-approved clinical trials of a phage drug and the first application for a drug targeting adherent-invasive E. coli (AIEC), a strain of E. coli found in patients with Crohn's disease.

Development of the drug began in 2015, and clinical trials will begin in 2018, lasting at least 1.5 years. The authors note that approval for clinical trials of the phage preparation is important not only for this drug but for phage therapy in general.

Interest in the microbiome—the community of microorganisms that inhabit the human body—is currently growing. Understanding the crucial role of these microorganisms in physiological processes is driving scientists to explore targeted therapies for conditions such as Crohn's disease. Bacteriophages, unlike antibiotics, provide targeted destruction of specific strains or species of bacteria. This helps maintain the natural balance of microflora, particularly in the gut.

The developers of the phage preparation that will be tested emphasize that AIEC is not the cause of Crohn's disease, but it plays a role in its pathogenesis, so the elimination of this strain of E. coli could become an important component of treatment.