Organovo Holdings announced a clinical program for FXR 314, 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 that it would first begin Phase 1 trials in 2025. The Company plans to give guidance on Phase 2 timelines after an internal determination of the best path forward. The Company continues to expect to file INDs starting in 2025 from fully internally developed molecules and expects to issue additional guidance on clinical plans in the coming months.
Published first on TheFly
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