In 2019, two clinical trials of phage preparations will begin in the United States.

The first is a randomized, double-blind, placebo-controlled, phase 1/2a interventional study of the safety and efficacy of a new phage drug in the treatment of Crohn's disease.

Crohn's disease is a chronic, nonspecific inflammation of the gastrointestinal tract. The causes of the disease remain unclear, but it is known that increased inflammation and other pathological symptoms are associated with the presence of so-called adherent-invasive Escherichia coli (AIEC).

The experimental drug is a cocktail of several bacteriophages specific to AIEC. The bacteriophages are capable of destroying AIEC without disrupting normal intestinal microflora. Furthermore, the bacteriophages are effective against antibiotic-resistant AIEC strains.

Patients with inactive Crohn's disease are participating in the study. They will receive the phage preparation orally twice daily for 15 days. For six months from the start of treatment, participants will be monitored for side effects, as well as the effect of the phages compared to placebo on Crohn's disease activity, the degree of inflammation, and the presence of AIEC in their stool.

The second clinical trial will be the first for IPATH , the only phage therapy center in the United States, which opened last year at the University of California, San Diego School of Medicine. This will be a Phase 1/2 clinical trial to study the safety, tolerability, and efficacy of intravenous administration of an experimental bacteriophage preparation for the treatment of patients with ventricular assist devices (VADs) infected with antibiotic-resistant Staphylococcus aureus . Patients will receive bacteriophages in combination with antibiotics. The plan is to enroll approximately 10 patients in the trial. IPATH already has experience treating this condition.

A VAD is an automatic pumping device that supports the heart and replaces either the right or left ventricle. A serious problem with the use of such devices is the formation of bacterial biofilms on their surface, which are resistant to traditional antibiotic therapy.