ONVO Announces Very Positive Phase 2 Results

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By Brad Sorensen, CFA

NASDAQ:ONVO

READ THE FULL ONVO RESEARCH REPORT

Organovo Holdings (NASDAQ:ONVO) is a biotechnology company that is both a developer of 3D tissue technology that has the potential to change the way treatments are discovered and tested, as well as being a creator of new therapies using that technology.

The company recently released Phase 2 results for one of the therapies being advanced by ONVO by the name of FXR 314. The trial was to determine the effectiveness of FXR314 in treating metabolic function-associated steatohepatitis (MASH), which is a condition affecting approximately 115 million people worldwide according to the Boehringer Institute, which is expected to increase by roughly 25% by 2050. MASH, briefly, is a condition that can develop when excess fat is stored in the liver and causes inflammation of the liver, which can lead to a variety of problems, including liver failure. The serious nature of this condition is part of the reason we are excited about results from the Phase 2 trial, which showed a significant reduction in liver fat content for trial participants, with a mean reduction of 23% for those with 3 mg doses of FXR314, compared to a 6.1% reduction seen in those participants with a placebo.

Additionally, the company found that FXR 314 was found to be safe and effective. CEO Keith Murphy noted that, “The key findings of this study are that the once daily oral FXR314 demonstrated statistically significant liver fat reduction and excellent tolerability.”

These results reinforce our belief that ONVO is pursuing a path for developing drugs that is more effective and efficient and should prove to produce more impactful treatments.

As mentioned above, the company is a developer of 3D technology as well as a creator of new therapies. It is this dual path and how the two paths can work together that continues to excite us about Organovo. Regarding the 3D technology, Organovo’s advances in the area include cell type-specific compartments, prevalent intercellular tight junctions, and the formation of microvascular structures. Management believes these attributes can enable critical complex, multicellular disease models that can be used to develop clinically effective drugs across multiple therapeutic areas. The company’s technology, known as NovoGen Bioprinters, are automated devices that enable the fabrication of 3D living tissues comprised of mammalian cells. The Company believes that the use of its bioprinting platform as well as complementary 3D technologies will allow it to develop an understanding of disease biology that leads to validated novel drug targets and therapeutics to those targets to treat disease. To this point, the company’s technology has been used to create a wide variety of tissues such as: healthy liver, NASH (nonalcoholic steatohepatitis) liver, kidney, intestine, skin, vascular, bone, skeletal muscle, eye, breast and pancreatic tumor.