Eli Lilly acquires Organovo’s FXR agonist for US $10M upfront

USA – Eli Lilly has secured full global rights to Organovo Holdings’ FXR agonist program, aimed at treating inflammatory bowel disease (IBD), with a US $10 million upfront payment and up to US $50 million in milestone payments.

The deal, disclosed in a Securities and Exchange Commission (SEC) filing, includes FXR314, a Phase II asset previously tested for ulcerative colitis (UC) and metabolic dysfunction-associated steatohepatitis (MASH).

Following the announcement, Organovo’s stock soared by 243%, reflecting investor confidence in FXR314’s potential.

The drug targets farnesoid X receptor (FXR), a nuclear hormone receptor involved in carbohydrate and lipid metabolism, insulin regulation, and liver regeneration.

Phase II trial results for FXR314 in MASH, presented in November 2024, showed a significant reduction in liver fat content, with the highest dose achieving a 22.8% reduction, compared to 6.1% in the placebo group.

Additionally, a higher proportion of patients on FXR314 achieved a 30% liver fat reduction, and the drug demonstrated a favorable safety profile.

Despite its MASH potential, Organovo’s agreement with Lilly focuses on IBD, with a Phase II trial set to begin in Q4 2025. The company has previously hinted at FXR314’s possible use in metabolic liver diseases and oncology.

FXR agonists have faced setbacks in MASH treatment. Intercept Therapeutics’ Ocaliva (obeticholic acid) failed to secure FDA approval for MASH in 2023, leading to major layoffs.

A second rejection for primary biliary cholangitis (PBC) further reinforced concerns about FXR-based therapies.

Alternative treatments are gaining ground. In March 2024, the FDA approved Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), a THRB agonist, as the first-ever drug for MASH.

Lilly also recently invested US $630 million in OliX Pharmaceuticals’ RNAi-based OLX75016 for MASH treatment.