Eli Lilly pays $10 million upfront for Organovo’s FXR agonist

Eli Lilly, a pharmaceutical company, has recently made a significant investment in Organovo Holdings, a biotechnology company based in San Diego. The deal involves a $10 million upfront payment for the exclusive global rights to Organovo’s farnesoid X receptor (FXR) agonist program, which is designed to address inflammatory bowel disease (IBD).

This collaboration between Lilly and Organovo aims to advance the development of FXR314, Organovo’s leading asset, which targets the FXR, a nuclear hormone receptor critical for regulating various metabolic processes in the body, including carbohydrate and lipid metabolism, insulin sensitivity, and liver regeneration. FXR314 has shown promising results in Phase II trials for metabolic dysfunction-associated steatohepatitis (MASH), a condition characterized by liver fat accumulation.

Organovo recently reported significant findings from a Phase II trial of FXR314 in MASH, demonstrating a substantial reduction in liver fat content compared to a placebo. Patients receiving FXR314 also experienced improved outcomes, with a higher proportion achieving significant reductions in liver fat. Importantly, the drug exhibited a favorable safety profile, encouraging further exploration of its therapeutic potential.

Despite the challenges faced by FXR agonists in the treatment of MASH, Organovo remains optimistic about the future of FXR314. Following Lilly’s investment, Organovo has shifted its focus to the development of FXR314 for IBD, intending to initiate a Phase II trial in the fourth quarter of 2025. The decision to reprioritize the drug’s development reflects Organovo’s strategic alignment with Lilly’s interests and expertise.

The pharmaceutical landscape for MASH treatment has seen recent advancements, with new drug approvals and innovative approaches gaining momentum. While FXR agonists have encountered setbacks, alternative mechanisms of action, such as THRB agonists, have shown promise. For instance, Madrigal Pharmaceuticals secured FDA approval for Rezdiffra, a THRB agonist, for MASH in March 2024, signaling a shift in treatment strategies for the condition.

In light of these developments, Lilly’s strategic investment in Organovo’s FXR program underscores the growing interest in novel therapeutic approaches for complex diseases like IBD and MASH. By combining their resources and expertise, Lilly and Organovo aim to accelerate the development of FXR314, potentially offering new treatment options for patients with IBD and other related conditions.

Overall, the collaboration between Lilly and Organovo represents a significant milestone in the field of biopharmaceutical research, highlighting the importance of innovative partnerships in advancing the development of novel therapeutics for challenging medical conditions. As both companies continue to explore the potential of FXR agonists in IBD and beyond, the future of precision medicine looks increasingly promising.