Organovo presents FXR314 3D human tissue model findings

Organovo 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. “There is a critical need for novel approaches to treat inflammatory bowel disease that extend beyond modulating the immune response targeted by current pharmacological therapies. These data underscore the potential of FXR314 as a unique treatment approach to IBD given its demonstrated multifaceted activity profile, especially in directly improving the intestinal barrier function and controlling fibrosis,” said Dr. Fabrice Piu, Vice President, Research & Development. 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. In ulcerative colitis, FXR314 improved epithelial barrier function and fibrotic activity in all donors. Organovo 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.