Inflammatory Bowel Disease (IBD) is a condition that causes inflammation in the colon and small intestine. Eli Lilly, a pharmaceutical company, has decided to pay $10 million upfront to acquire global rights to a program developed by Organovo Holdings, a company based in San Diego. This program involves a drug that targets the farnesoid X receptor (FXR) and is intended to treat IBD.
As part of the agreement, Lilly will pay an initial $10 million and potentially up to $50 million more if certain milestones are reached. This deal includes a drug being tested in Phase II trials for conditions like ulcerative colitis (UC) and a liver condition known as MASH. After the announcement, Organovo’s stock prices increased significantly.
The drug, called FXR314, works by targeting a receptor that is important for managing metabolism and liver health. In a 2024 trial, FXR314 showed promising results in reducing liver fat in patients with MASH, with some patients seeing more than a 30% reduction. The drug was also found to be safe.
While Organovo was initially excited about using FXR314 for MASH, the focus has shifted to IBD. They plan to start Phase II trials for IBD in late 2025. Despite challenges faced by other companies with similar drugs, like Intercept Therapeutics’ Ocaliva, which was not approved by the FDA, Organovo is continuing with FXR314’s development.
New methods are emerging for MASH treatment, such as Madrigal Pharmaceuticals’ drug Rezdiffra, which became the first FDA-approved treatment for MASH in March 2024. Eli Lilly is also investing in other treatments, such as a $630 million deal with OliX Pharmaceuticals for a new drug to treat MASH.