Organovo highlights FXR314 combination therapy potential, plan

Organovo announced its intention to study combination therapy in inflammatory bowel disease and release data in calendar Q3 2024. The Company believes that the data it can generate can be powerful in establishing a strong use case for FXR314 in patients, and provide support for collaborations with major pharmaceutical companies currently offering IBD treatments. The differentiated mechanism of action of FXR314 provides substantial promise that the drug’s impact will strongly complement the biology of other successful drugs in the space, e.g. TNF-alpha inhibitors, IL-12/23 inhibitors, and JAK inhibitors. In both Organovo’s proprietary 3D human models and in preclinical animal models of disease, FXR314 treatment demonstrates a reduction in the disruption of the intestinal lining, which protects against bacteria penetrating into the intestinal wall. Further, our models and published literature indicate a role of FXR314 in modulating responses in innate lymphoid cells in the intestine, preventing the cytokine release that triggers a systemic immune-inflammatory response. “We remain excited about the potential of FXR314 to treat IBD due to its unique mechanism of action, and about our upcoming Phase 2 study to demonstrate its activity in ulcerative colitis,” said Keith Murphy, Organovo Executive Chairman. “As we enroll patients and complete the Phase 2, we are eager to explore the drug’s potential for combination therapy and share our findings and the opportunities we see to further benefit patients, some of whom don’t benefit from existing therapies due to safety limitations or low response rates. There remains great unmet need in inflammatory bowel disease, and we look forward to defining multiple roles FXR314 can play in providing treatment solutions.”