Organovo announces details on its clinical program for FXR314

Organovo 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.”Phase 1 safety data for FXR314, the data in our 3D human models of ulcerative colitis, and preclinical models all show very positive promise for FXR314 in the treatment of ulcerative colitis,” said Keith Murphy, Organovo’s Founder and Executive Chairman. “We believe strongly that the fact that FXR314 is showing effects on disease in our 3D human cellular models of ulcerative colitis means that it has a greater likelihood of success in Phase 2 than a typical drug program. We are excited to be charting a path to clinical success in ulcerative colitis, while also seeking to unlock the drug’s strong potential in NASH, where it has shown great promise in early clinical trials.”