SAN DIEGO, Calif. — Organovo Holdings, Inc. (Nasdaq: ONVO), a clinical stage biotechnology company focused on developing FXR314 in inflammatory bowel disease (IBD), including ulcerative colitis, based on demonstration of clinical promise in three-dimensional (3D) human tissues, today 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.
“There is a critical need for novel approaches to treat inflammatory bowel disease (IBD) 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 Crohn’s and Colitis Congress is a unique opportunity to demonstrate this potential among key thought leaders in the field and as we continue to drive our program forward.”
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’s primary multicellular 3D human IBD models constitute a powerful tool to more accurately predict the relevance of specific targets and assess the efficacy of therapeutic candidates. We strongly believe these results increase the probability of success with FXR314 when conducting IBD clinical trials, due to its demonstrated comparability to known disease,” added Keith Murphy, Organovo’s Executive Chairman.
Organovo’s current development program for FXR314 focuses on inflammatory bowel disease, where the drug’s differentiated mechanism of action, as highlighted in Organovo’s recently provided mechanism of action video at https://organovo.com/about/, provides substantial promise that the drug’s impact will strongly complement the biology of other successful drugs in ulcerative colitis and Crohn’s disease. 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.
About Organovo
Organovo is a clinical stage biotechnology company that is developing drugs that are demonstrated to be effective in three-dimensional (3D) human tissues as candidates for drug development. The company’s lead molecule, FXR314, is on the path for Phase 2 investigation in inflammatory bowel disease and has potential application in metabolic liver disease and oncology. The company has proprietary technology used to build 3D human tissues that mimic key aspects of native human tissue composition, architecture, function and disease.
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