Clinical Trial Demonstrates Reduction In Liver Fat And Improvement In Liver Function Tests

Organovo Announces Positive Phase 2 Results for FXR314 in Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD)

Clinical Trial Demonstrates Reduction in Liver Fat and Improvement in Liver Function Tests

Organovo's Lead Therapeutic Candidate Continues to Advance with Promising Results

San Diego, CA - January 25, 2024 - Organovo Holdings Inc. (NASDAQ: ONVO), a leading biotechnology company focused on developing novel 3D bioprinted tissues and organs, today announced positive results from its Phase 2 clinical trial evaluating FXR314, its lead therapeutic candidate, for the treatment of Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).

The Phase 2 trial, which enrolled 120 patients with MAFLD, evaluated the safety and efficacy of two doses of FXR314 compared to placebo over a 12-week treatment period. The primary endpoint of the trial was the change in liver fat content as measured by magnetic resonance imaging (MRI-PDFF). Results showed that both doses of FXR314 significantly reduced liver fat content compared to placebo, with a dose-dependent response observed.

"We are very encouraged by the results of this Phase 2 trial, which provide further evidence of the therapeutic potential of FXR314," said Dr. Keith Murphy, Chief Medical Officer of Organovo. "The reduction in liver fat and improvement in liver function tests observed in this study suggest that FXR314 may have the potential to address the unmet medical need for an effective treatment for MAFLD."

MAFLD is a chronic liver disease characterized by the accumulation of fat in the liver. It is the most common chronic liver disease worldwide, affecting approximately 25% of the population. MAFLD can lead to liver damage, cirrhosis, and liver failure. There are currently no approved treatments for MAFLD.

"These Phase 2 results provide a solid foundation for advancing FXR314 into Phase 3 development," said Dr. Gavin Corcoran, Chief Scientific Officer of Organovo. "We believe that FXR314 has the potential to transform the treatment of MAFLD and provide new hope for patients living with this condition."

Organovo plans to initiate a Phase 3 trial in MAFLD in the second half of 2024. The Phase 3 trial will be a global, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of FXR314.