Eli Lilly (LLY.US) acquires Organovo's FXR project and flagship therapy FXR314 for treating ulcerative colitis.

Organovo Holdings announced today that Eli Lilly and Company will acquire its FXR project and lead therapy FXR314. FXR314 is a potential "best-in-class" oral FXR small molecule agonist. Currently, Organovo has obtained clinical trial approval from the US FDA and is conducting Phase 2 trials of its lead therapy FXR314 for the treatment of ulcerative colitis (UC). The company has developed an efficient clinical development strategy for FXR314 based on its proprietary 3D human tissue models, which is not only applicable to ulcerative colitis but also to other inflammatory bowel diseases including Crohn's disease. Organovo is also advancing the application of FXR314 in the treatment of liver diseases, including non-alcoholic steatohepatitis (NASH) and primary biliary cholangitis. Preliminary clinical trial results show that FXR314 is highly effective, safe, and well tolerated, with the potential to avoid the dose-limiting toxicities commonly seen with other FXR-targeted drugs. Under the agreement, Organovo will receive an upfront payment and will receive corresponding payments upon the achievement of key regulatory and commercial milestones for FXR314. Eli Lilly will acquire all commercial development rights for Organovo's FXR project globally.