Bacainn is developing novel therapies that target the innate immune system to address unmet needs in serious gastrointestinal and respiratory diseases
BT051 in Moderate to Severe Ulcerative Colitis
This first in-human study of BT051 was a randomized, double-blind, placebo-controlled, single-center, single ascending dose (SAD) study. Fifty healthy subjects were dosed with BT051 (n=40) or placebo (n=10). No dose-limiting toxicities, serious AEs or study discontinuations due to AEs were observed. Nine (22.5%) BT051 subjects and two (20%) placebo subjects experienced at least one mild or moderate AE with only vessel puncture site pain and constipation reported in more than one subject treated with BT051. No evidence of systemic T-cell immunosuppression was observed at any dose level. Mean percentage dose excreted in stool from partial collection ranged between 11.3-26.3%. At all doses tested, concentrations of BT051 in the large intestine were estimated to be at least 20-fold above the threshold for inhibition of neutrophil transmigration and activation.
For more information on our Phase 1a trial