Eli Lilly invests US$10M in Organovo’s FXR Agonist for IBD development

USA – Eli Lilly has entered into an agreement with San Diego-based Organovo Holdings to acquire full worldwide rights to its farnesoid X receptor (FXR) agonist programme, aimed at treating inflammatory bowel disease (IBD).

The deal includes a US$10 million upfront payment and up to US$50 million in milestone payments, according to a Securities and Exchange Commission (SEC) filing.

Central to the agreement is Organovo’s lead asset, FXR314, which has already been evaluated in a Phase II trial for metabolic dysfunction-associated steatohepatitis (MASH) and ulcerative colitis (UC). The company’s shares surged by 243% following the announcement on February 25.

FXR314 targets FXR, a nuclear hormone receptor involved in regulating carbohydrate and lipid metabolism, insulin sensitivity, and liver regeneration.

In November 2024, Organovo released Phase II data (NCT04773964) showing that FXR314 led to a statistically significant reduction in liver fat content in MASH patients.

At its highest dose, FXR314 achieved a 22.8% mean reduction compared to 6.1% in the placebo group. A larger proportion of patients also achieved more than a 30% fat reduction, with the drug maintaining a favourable safety profile.

Despite the promising MASH data, Organovo’s latest announcement with Lilly focuses exclusively on IBD.

A Phase II trial for IBD is slated to begin in Q4 2025. Previously, Organovo indicated FXR314 might also have applications in metabolic liver diseases and oncology.

The partnership comes amid broader skepticism about FXR agonists in MASH, following setbacks like Intercept Therapeutics’ failed bid to gain FDA approval for its FXR agonist, Ocaliva, in both MASH and primary biliary cholangitis (PBC). These failures led to workforce cuts and cast doubt on FXR-targeted therapies.

Meanwhile, alternative mechanisms have gained traction. Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), a THRB agonist, became the first FDA-approved MASH therapy in March 2024.

Just this month, Lilly also announced a US$630 million deal with OliX Pharmaceuticals for OLX75016, an antisense RNAi oligonucleotide for MASH treatment.

Known as OLX75016, the candidate is an antisense RNAi oligonucleotide developed using OliX’s therapeutic RNAi platform. OliX focuses on developing therapies by inhibiting the expression of genes that cause disease through its technology.

Lilly will make an initial payment to complete a Phase I trial that kicked off in Australia in February 2024. The study, set to enrol 58 healthy subjects, will evaluate the safety and tolerability of single and multiple ascending doses of OLX75016.

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