SAN DIEGO - Organovo Holdings, Inc. (NASDAQ:ONVO), a biotech company focusing on 3D human tissues for medical research and therapeutic applications, today announced positive results from its Phase 2 clinical trial for FXR314, a treatment candidate for metabolic function-associated steatohepatitis (MASH).
The multi-center, randomized, placebo-controlled study, which lasted 16 weeks, showed a significant reduction in liver fat content among patients who were administered FXR314. Patients treated with 3 mg and 6 mg doses of FXR314 experienced a liver fat reduction of 22.8% and 17.5% respectively, compared to a 6.1% reduction in the placebo group.
Additionally, 29.2% of subjects on the 3 mg dose and 32.2% on the 6 mg dose achieved more than a 30% reduction in liver fat, as measured by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF), which was significantly higher than the 9.5% observed in the placebo group.
The trial also reported improvements in hepatocellular damage and liver function without worsening liver fibrosis. The treatment was found to be safe and well-tolerated, with minimal treatment discontinuation due to drug-related adverse events. Notably, FXR314 did not exhibit common adverse events associated with the FXR agonist class, such as significant pruritus or LDL-C level changes.
Keith Murphy, Executive Chairman of Organovo, expressed optimism about FXR314, highlighting its favorable profile compared to other FXR agonists, which have historically faced challenges in demonstrating clear benefits without significant side effects. Murphy indicated that the data support further clinical development of FXR314 for MASH treatment.
The study enrolled 214 MASH patients with liver fat content of 10% or higher, as measured by MRI-PDFF. Participants were randomized to receive either 3 mg or 6 mg of FXR314 or a placebo, with treatment administered orally once daily.
Detailed findings from the study (Clinical trial registry NCT047773964) are expected to be presented at an upcoming medical conference. Organovo plans to continue the investigation of FXR314, which also has potential applications in inflammatory bowel disease and oncology.
The information in this article is based on a press release statement from Organovo Holdings, Inc.
InvestingPro Insights
As Organovo Holdings, Inc. (NASDAQ:ONVO) continues to make strides in the development of its FXR314 treatment for metabolic function-associated steatohepatitis (MASH), investors and analysts are closely monitoring the company's financial health and market performance. According to the latest data from InvestingPro, Organovo's market capitalization stands at a modest $10.14 million USD. However, the company's P/E ratio is currently negative at -0.47, reflecting challenges in profitability, which aligns with an "InvestingPro Tip" that analysts do not expect the company to be profitable this year.
Moreover, Organovo's revenue over the last twelve months as of Q3 2024 is reported at $0.24 million USD, with a significant revenue decline of -85.83% during the same period. This is consistent with another "InvestingPro Tip" that analysts anticipate a sales decline in the current year. The company's gross profit margin also stands at an alarming -3571.49%, underscoring the "InvestingPro Tip" regarding weak gross profit margins that the company is currently experiencing.
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