Organovo Holdings, Inc. (NASDAQ:ONVO) shares are trading higher Monday after the company announced Phase 2 results for FXR314.
The Details:
Organovo released the 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).
Study results demonstrated statistically significant reduction in liver fat content from baseline in patients receiving FXR314 compared to placebo, and FXR314 was also found to be safe and well tolerated.
“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 ...