Organovo Holdings, Inc. announced the presentation of preclinical data related to the company's FXR314 development program in its proprietary 3D human tissue models of Crohn's disease and ulcerative colitis at the Crohn's and Colitis Congress being held January 25-27, 2024 in Las Vegas, Nevada. FXR314 is a clinical-stage potent, selective, orally administered non-bile acid FXR agonist being developed as a novel therapeutic approach for IBD. The presentation highlights preclinical data characterizing the activity of FXR314 in 3D models of human Crohn's disease and Ulcerative colitis.

FXR314 broadly improved measures of epithelial barrier function in a subset of donors, and fibrotic markers in all Crohn's disease donors. The company plans to begin enrollment for a proof-of-concept Phase 2 ulcerative colitis study in 2024, with targeted completion in 2025. The drug?s additional promise in liver fibrosis and NASH makes it a strong candidate for development in that.