Novel Bacterial Therapy Appears Safe for Ulcerative Colitis

Alternatives to mesalamine for mild to moderately active ulcerative colitis are currently under investigation. SER-287 is a novel preparation of colonic bacteria. In an industry-funded phase Ib trial, 58 patients were randomized to receive either Firmicutes bacterial spores (weekly or daily) or placebo following a week of placebo or vancomycin. The primary endpoints were safety and changes in microbiome composition.

After 8 weeks of therapy, there were no differences in the proportion of adverse events among treatment arms. In those patients given vancomycin prior to treatment, there was a sustained increase in species count by day 10, suggesting successful engraftment. Clinical remission was achieved in 40% of the daily treatment group vers…