Organovo Presents Clinical Data of FXR314 in Phase 2 MASH in an Oral Presentation at The Liver Meeting

Core Insights - Organovo Holdings, Inc. is a clinical stage biotechnology company focused on developing treatments for inflammatory bowel disease (IBD) including ulcerative colitis [1] - The company's lead drug FXR314 was presented at The Liver Meeting, highlighting its potential in treating metabolic dysfunction-associated steatohepatitis (MASH) [1][2] Study Results - A Phase 2 study of FXR314 involved 214 patients, randomized to receive either 3 mg or 6 mg of FXR314, or a placebo [3] - FXR314 demonstrated a statistically significant reduction in liver fat content, with a 22.8% reduction for the 3 mg group (p=0.0010) and 17.5% for the 6 mg group (p=0.0267), compared to 6.1% in the placebo group [4] - The proportion of subjects achieving over 30% reduction in liver fat was 29.2% for the 3 mg group and 32.2% for the 6 mg group, compared to 9.5% in the placebo group [4] Safety Profile - FXR314 was found to be safe and well tolerated, with treatment-emergent adverse events mostly mild to moderate [5] - The incidence of pruritus was low, with 2.8% in the 3 mg group, 4.2% in the 6 mg group, and 2.8% in the placebo group [5] - Drug-related treatment discontinuation rates were low and similar across all groups [5] Future Prospects - Dr. Lawitz expressed optimism about FXR314's unique profile, indicating potential for further evaluation in treating MASH [6] - Organovo is also developing drugs that are effective in three-dimensional human tissues, with FXR314 being a candidate for both inflammatory bowel disease and metabolic liver disease [6]