BiomX has reported top-line findings from a phase 1a clinical trial of its orally administered phage therapy candidate BX002. The study provided early evidence BiomX can get the high concentrations of viable phage to the gastrointestinal tract needed to make oral administration a feasible option.
There is a long history of administering phages orally, as well as locally, rectally and intravenously, to prevent and treat bacterial infections. However, a lot of the data on oral phage administration were generated years ago in the Soviet Union and outside of clinical trials. BiomX framed its results as the first time oral phage delivery has been “demonstrated rigorously in a clinical study.”
The study randomized 18 healthy adult volunteers to take either a bacteriophage cocktail or placebo in the form of a 1-mL liquid for multiple-dose oral administration. BiomX then assessed the levels of viable phage in the stools of the participants through to Day 6 of the clinical trial.
Based on the plaque-forming unit analysis, BiomX concluded BX002 can deliver high concentrations of viable phage to the gastrointestinal tract. BiomX calculated it got 10^10 plaque-forming units into the gastrointestinal tracts of patients.
The Israeli biotech framed the figure in the context of the Klebsiella pneumoniae bacterium BX002 is designed to target. According to BiomX, the level of plaque-forming units seen in the study is equal to approximately 1,000 times more viable phage compared to the bacterial burden of K. pneumoniae in people with inflammatory bowel disease and primary sclerosing cholangitis, as measured in stool.
BiomX is now gearing up to evaluate the efficacy of its phages in patients with inflammatory bowel disease and primary sclerosing cholangitis. The phase 1b/2a study will evaluate the efficacy of a new candidate, BX003, designed to work in both indications. BiomX expects to have top-line data around the middle of next year.