Organovo Advances Timelines for Ulcerative Colitis, Updates on NASH Phase 2

 Organovo Holdings, Inc. (Nasdaq: ONVO) (Organovo), a clinical stage biotechnology company that is focused on developing novel human therapies with demonstrated function in high fidelity three-dimensional (3D) tissues that recapitulate key aspects of human disease, today announced more details about its clinical program for FXR314, an FXR agonist that has completed initial clinical trials. FXR314 is a drug with safety and tolerability after daily oral dosing in Phase 1 and Phase 2 trials. Further, FXR314 has FDA clinical trial authorization for a Phase 2 trial in ulcerative colitis.

Organovo’s FXR program announcement updates its previous guidance on clinical trial starts for the company, with the Company accelerating its timeline to first clinical trials by approximately two years. The Company previously announced in March 2023 that it would give guidance on Phase 2 timelines for FXR314 after an internal determination of the best path forward. The Company continues to expect to file INDs starting in 2025 for fully internally developed molecules and expects to issue additional guidance on pipeline programs in the coming months.

In addition, Organovo is anticipating the release of final Phase 2 data on the performance of FXR314 in NASH. Performance of the drug to date in treatment of NASH has been encouraging. Interim results in Phase 2 showed that FXR314 lowered liver fat content, with mean relative reductions of 26.9±27.8 percent in the 3 mg cohort and 9.3±55.8 percent in the 6 mg cohort, compared with 7.5±21.0 percent in the placebo cohort. Median liver fat reduction was 28.6 percent in the 3 mg cohort, 26.9 percent in the 6 mg cohort compared to 1.5% in the placebo arm. A post-hoc comparative assessment of relative liver fat reduction in the interim cohort found the decrease with the 3 mg dose to be statistically significant compared to placebo (p=0.006). FXR314 achieved greater than 30 percent liver fat reduction in 47 percent of patients (8/17) in the 3 mg cohort and 35 percent (6/17) in the 6 mg cohort, compared with 12 percent (2/17) in the placebo arm. To date, the drug has been generally well-tolerated, with no treatment-related serious adverse events. All treatment-related adverse events have been mild-moderate with no apparent dose relationship. Full Phase 2 data is expected to be released in 1H 2024.

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