Organovo Reports Positive Phase 2 Data for FXR314 in MASH

April 15, 2024

DENVER, Colo., Apr 15, 2024 (247marketnews.com)- Organovo Holdings, Inc. (NASDAQ:ONVO) reported complete details of its 16-week, randomized, placebo-controlled, multi-center Phase 2 study of the non-steroidal, non-bile acid FXR agonist FXR314 for the treatment of metabolic function-associated steatohepatitis (MASH), which demonstrated statistically significant reduction in liver fat content from baseline in patients receiving FXR314 compared to placebo.

“The key findings of this study are that once daily oral FXR314 demonstrated statistically significant liver fat reduction and excellent tolerability. Whereas other FXR agonists have had challenges in providing clear benefit without significant pruritus or other adverse events, or have had lack of efficacy potentially related to lack of sustained exposure, we are pleased to note FXR314’s data demonstrate it clearly rises above previous problems seen with the class,” said Keith Murphy, Organovo’s Executive Chairman. “Given these exciting findings, we believe the data are supportive of further clinical development of FXR314 in MASH.”

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