Organovo unveiled positive preclinical data for the transplantation of its 3D-bioprinted human liver tissue into diseased animal models.
The company has previously implanted the liver tissue into healthy animals and presented that data last December. Patches of the transplanted tissue, made up of hepatocytes and nonparenchymal cells, stayed intact, performed liver function and were well tolerated after four weeks.
The new data, presented at the World Advanced Therapies and Regenerative Medicine Congress, showed the diseased animals accepted and retained the bioprinted tissue. The data also showed that the liver tissue functioned for 60 days after implantation, the company said.
A pathologic assessment of the animals showed that those that received the bioprinted liver tissue had improved liver health over untreated animals, according to a statement.
Organovo is working on bioprinted tissue for therapeutic use in humans. Its first target will be pediatric inborn errors of metabolism and it plans to develop and finalize its liver tissue design over the next 18 months. The company expects to file an Investigational New Drug application in 2020.
“With tens of thousands of patients being treated for inborn errors of metabolism (“IEMs”) in the U.S., and an annual cost per patient that exceeds $250,000 for drug therapy alone, Organovo is advancing novel therapeutic solutions for direct surgical implantation," said Eric David, M.D., J.D., chief strategy officer and executive vice president of preclinical development, Organovo. “Our preclinical data continues to show increased durability of the liver tissue and strong early evidence of successfully impacting the disease state in animal models. The robust presence of key human metabolic enzymes, which we previously disclosed, is also a critical step in demonstrating the capability of this tissue to treat IEMs.”
The company is also working on bioprinted tissue, including liver and kidney tissue, for use in clinical trials.