CONCORD, Mass.–(BUSINESS WIRE)–Bacainn Therapeutics, Inc., a biotechnology company focused on developing novel therapies that target the innate immune system to address uncontrolled inflammation, today presented results at the European Crohn’s and Colitis Organisation’s 2021 Virtual Congress from a Phase 1 study that showed its lead asset BT051 was safe and well-tolerated in healthy adults. BT051 is an oral, locally-acting inhibitor of neutrophil trafficking and activation and is in clinical development for the treatment of inflammatory bowel disease (IBD), which impacts as many as 6.8 million people in the United States and Europe.i,ii A gut-restricted inhibitor of MRP2 and FPR1, BT051 is designed to treat the source of chronic IBD inflammation by directly restoring healthy levels of neutrophil and epithelial cell pro-inflammatory activation, and indirectly via limiting T cell activation.
“In this Phase 1 study, single-dose administration of BT051 was generally safe and well-tolerated with minimal systemic exposure, while BT051 stool concentrations were significantly above the predicted efficacy range. Taken together, these data support the continued development of BT051 as a gut-targeted therapy for people with moderate-to-severe ulcerative colitis.”
“People with IBD need additional therapeutic options as their disease progresses,” said Chris Stevens, MD, Chief Medical Officer at Bacainn Therapeutics. “In this Phase 1 study, single-dose administration of BT051 was generally safe and well-tolerated with minimal systemic exposure, while BT051 stool concentrations were significantly above the predicted efficacy range. Taken together, these data support the continued development of BT051 as a gut-targeted therapy for people with moderate-to-severe ulcerative colitis.”
Details of Poster Presentation:
TITLE: Safety, tolerability and pharmacokinetics of BT051, an oral inhibitor of neutrophil migration and activation in clinical development for Inflammatory Bowel Disease
PRESENTATION NUMBER: P259
e-Poster Exhibition: Clinical: Therapy and Observation
TIMING: July 9, 2021 – Virtual, 08:30 – 17:45 CEST
AWARDED: Top-10 e-Poster with accompanying audio presentation of the data
About the Phase 1 Study
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.
About Bacainn Therapeutics
Bacainn Therapeutics is developing novel therapies that target the innate immune system to address uncontrolled inflammation in serious gastrointestinal and respiratory diseases. The company embraces the latest insights into innate immunity to guide bold, new approaches for treating inflammatory diseases differently. Founded in 2017, Bacainn is funded by Morningside Ventures. For more information, see https://bacainntherap1.wpengine.com.
i The Burden of inflammatory bowel disease in Europe, Journal of Chron’s and Colitis, Vol. 7, Issue 4, May 2013, pp322-337
ii CDC, Morbidity and Mortality Weekly Report. Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of inflammatory bowel disease among adults aged ≥18 years—United States, 2015. MMWR Morb Mortal Wkly Rep. 2016;65(42):1166–1169