In February 2021, the successful completion of a pharmacokinetic study of an oral phage preparation for the treatment of inflammatory bowel disease/primary sclerosing cholangitis in Phase 1a clinical trials under the FDA IND protocol was announced .

The phage preparation BX002, developed by the American biotechnology company BiomX, has an antibacterial effect against Klebsiella pneumoniae , which is involved in the pathogenesis of inflammatory bowel disease/primary sclerosing cholangitis (IBD/PSC).

A randomized, single-blind, multi-dose, placebo-controlled Phase 1a study examined the pharmacokinetics of oral BX002 under the FDA's Investigational Drug (IND) protocol. The study enrolled 18 healthy volunteers, 14 of whom received the phage preparation and 4 who received a placebo, twice daily for 3 days. Participants were observed in a clinical setting for 7 days and then assessed on days 14 and 28 after the last dose. High concentrations of live bacteriophages (approximately 1010 CFU/mL) were detected in the lower intestines of all participants receiving the phage preparation. This bacteriophage concentration is 1000 times higher than the concentration of K. pneumoniae in the stool of patients with PCO and PCH. The phage preparation BX002 demonstrated safety, good tolerability, and the absence of severe side effects or effects that would lead to treatment interruption.

This is the first clinical trial to demonstrate effective delivery of live bacteriophages via oral administration, in accordance with current FDA protocols. Bacteriophages were delivered to the lower intestine in quantities sufficient to treat K. pneumoniae infection in patients with PCO/PHG.

The developers of the phage preparation are already preparing to conduct the next phase of trials, 1b/2a, in which the effectiveness of the drug against K. pneumoniae will be studied.