Organovo announces Phase 2 results for FXR314

Organovo Holding released the complete details of its 16-week, randomized, placebo-controlled, multi-center Phase 2 study of the non-steroidal, non-bile acid FXR agonist FXR314 for the treatment of metabolic function-associated steatohepatitis, MASH. Study results demonstrated statistically significant reduction in liver fat content from baseline in patients receiving FXR314 compared to placebo. Study subjects receiving FXR314 achieved statistically significant reduction in liver fat content from baseline, with LS mean percent reduction at end of treatment of 22.8% with 3 mg and 17.5% with 6 mg doses of FXR314 compared to 6.1% in the placebo group. The proportion of subjects with greater than30% magnetic resonance imaging-derived proton density fat fraction reduction was 29.2% and 32.2% for 3 mg and 6 mg FXR314, respectively, compared to 9.5% with placebo. Investigators observed improvements in hepatocellular damage and liver function based on serological measures, with no evidence of worsening of liver fibrosis. FXR314 was also found to be safe and well tolerated.