Can Organovo Leverage Its Solid Phase II Data In MASH?

Cash-limited Organovo has an FXR agonist showing competitive efficacy and tolerability in MASH, but may need a partner to move forward in that disease as it may be prioritizing its IBD program.

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Organovo's candidate shows better pruritus data than others in its class.

The idea of an FXR agonist being the solution for treating metabolic function-associated steatohepatitis (MASH) took a substantial hit when Intercept Pharmaceuticals, Inc. ended development of obeticholic acid (OCA) in the disease. However, Organovo Holdings, Inc. has now reported Phase II data for an FXR agonist that shows hepatic fat-reducing ability as well as a cleaner safety and tolerability profile than typically seen with the drug class.

Key Takeaways
  • Organovo, which uses its bioprinting capabilities to produce 3D disease models, reported Phase II data in MASH that looks competitive compared to other FXR agonists.

  • The company’s primary therapeutic focus is on inflammatory bowel disease, where it is planning a Phase II study in ulcerative colitis with the same compound, FXR314

Previously focused on bioprinting, research tools and tissue for direct therapy, Organovo in recent years has used its ability to create 3D-printed disease models to identify therapeutic approaches that might be superior to currently available drugs

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