Organovo Achieves Key Development Milestones

Organovo Holdings, Inc. recently announced that along with its collaborators, it has achieved several breakthrough capabilities for its 3D bioprinted tissues. At the International Liver Congress, two posters were presented illustrating the Company’s ability to create functional human liver tissue, produce a spectrum of NASH disease conditions, and then treat that disease successfully with a client’s development stage non-alcoholic steatohepatitis (NASH) drug. These posters highlighted the performance of Organovo’s human liver model in the generation of a robust non-alcoholic fatty liver disease (NAFLD) and NASH phenotype, including the presence of “gold standard” histopathologic features.

“No other in vitro modeling system allows drug researchers to explore the evolution of NASH and related treatment strategies using histology, the only accepted measurement for efficacy, based on visual confirmation of the cellular disease process under a microscope,” said Taylor J. Crouch, CEO, Organovo. “Industry leaders at the International Liver Congress spotlighted the need for measurable ways to explore the efficacy of the approximately 250 NASH drug programs in relevant, translatable human systems. Organovo’s ExVive tissue modeling capabilities represent a major advancement for drug development. We are particularly excited that we can work with clients to explore their clinical stage drug candidates, allowing them to address the patient specific needs of their drugs.”

Organovo continues to map out a range of relevant conditions for creating NASH, including all components of the disease (fat accumulation, inflammation, and fibrosis). In addition to assessing donor-specific susceptibility to NAFLD/NASH conditions, the company is also systematically testing major reference classes of compounds targeting NASH to inform treatment strategies. Ultimately, Organovo’s “patient-on-a-plate” platform allows researchers to conduct a broad range of high-value profiling studies in a more relevant, rapid, and cost-effective manner than traditional cell culture and animal models before committing significant resources to human clinical trials.

Organovo and Merck & Co. (Merck) also jointly published a peer-reviewed study describing the company’s bioprinted human intestinal model, which exhibits compelling architecture, barrier and metabolic functions, while also being able to model key aspects of toxicity and inflammation.

“The gut model is an exciting addition to our portfolio of high-value drug modeling platforms,” said Dr. Sharon Presnell, Chief Scientific Officer, Organovo. “Its performance and features outshine current in vitro systems, and also has the potential to facilitate systems biology approaches for the study of diseases, such as NAFLD and NASH, where disease initiation and progression involve significant interplay between the intestine and liver.”

Organovo is developing and commercializing a platform technology to produce and study living tissues that emulate key aspects of human biology and disease for use in drug discovery, clinical development, and therapeutic applications. The company develops tissue systems through internal research programs and in collaboration with pharmaceutical, academic, and other partners. Organovo’s living tissues have the potential to transform the drug discovery process, enabling treatments to be developed more effectively and with greater relevance to performance in human trials and commercialization. The company’s ExVive Liver and Kidney Tissues are used in disease modeling for NASH and fibrosis, high-value drug profiling, target and marker discovery/validation, and other drug testing. The company is also advancing a preclinical program to develop its NovoTissues liver therapeutic tissues for critical unmet medical needs, including certain life-threatening pediatric diseases. The company has received orphan designation for its potential treatment of alpha-1-antityrpsin deficiency, its lead indication within the category of inborn errors of metabolism. Organovo is changing the shape of life science research and transforming medical care. For more information, visit www.organovo.com.