Organovo Holdings, Inc. announced its intention to study combination therapy in inflammatory bowel disease and release data in calendar third quarter 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, as highlighted in Organovo's recently provided mechanism of action video at, 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 (such as Humira), IL-12/23 inhibitors (such as Stelara), and JAK inhibitors (such as Xeljanz).

The promise of combination therapy in this space is great, as all of these therapies have impactful safety signals. The ability to enable dosing half or less of the typical dose of these drugs, enabled by a combination with FXR314, could substantially reduce the safety impact and better serve patients. Further, FXR314 combination therapy could enable the successful achievement of clinical remission in a greater percentage of patients.

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, models and published literature indicate a role of FXR314 in modulating responses in innate lymphoid cells (ILCs) in the intestine, preventing the cytokine release that triggers a systemic immune- inflammatory response. In so doing, FXR314 can complement the typical drug therapies used in IBD, which themselves inhibit the activity of the cytokines driving the systemic response.

Since FXR314 has a target that is upstream of most currently prescribed drugs, it can potentially strongly complement the use of these drugs when used in combination. Organovo has previously announced plans for a Phase 2a study of FXR314 in ulcerative colitis, with a readout expected in 1H 2025. In addition, the company will now begin preclinical studies with combination therapies using FXR314 and currently approved therapies or equivalent that can benefit from lower dosing.

Further, over time the company expects to share data generated in its proprietary 3D human models of inflammatory bowel disease that further demonstrate the potential for combination effects.