Viscient Bio, Inc. has announced it has identified the world's first drug candidate discovered primarily using 3D bioprinted tissue models of disease formed from human cells. \n\n\n\nThe company said it expects to develop the drug to treat non-alcoholic steatohepatitis (NASH), a growing epidemic disease that is believed to affect more than 10% of the U.S. population. NASH can often lead to hepatocellular carcinoma or liver failure. Due to the devastating effects of NASH on patients and its wide prevalence, analysis has projected future pharma industry revenues for the drug in the tens of billions of dollars per year. \n\n\n\nViscient Bio's lead compound is an orally-delivered small molecule designed to hit a novel target identified in 3D bioprinted and other 3D tissue models of disease. In preclinical studies, the drug has proven to be well tolerated. In Viscient Bio's models of disease, the compound shows reduction of fibrosis as measured by histological evidence similar to that used for human liver biopsy. Using the same model, fibrosis reduction is also seen for obeticholic acid and resmetirom, while no fibrosis reduction is seen for drugs such as cenicriviroc, selonsertib, and elafibranor. The newly discovered target is predominantly expressed in liver tissue.\n\n\n\n"It is long past time to displace the model of drug development reliant on proof of activity in animals," said Viscient Bio chief executive officer Keith Murphy. \n\n\n\n"Viscient's trailblazing work has resulted in 3D cellular human models of disease in which the performance of previously tested compounds has matched clinical results. Failed NASH drugs never would have been put in humans based on what can be clearly seen in these models. Our novel compound shows fibrosis reduction in these models, as do NASH drugs known to work in phase 3, and we are excited to move this lead program forward."\n\n\n\nViscient Bio's model gives accurate predictions\n\n\n\nThe lead compound's clear reduction of fibrosis in Viscient Bio's NASH models is promising because Viscient Bio's 3D models of NASH have shown extremely high correlation with clinical results in patients. The model demonstrates fibrosis reduction for known clinical compounds tested by pharma companies that have that effect in humans, while revealing lack of fibrosis reduction for compounds that failed in phase 2 or phase 3 for NASH. \n\n\n\nThe model is accurate in predicting both successes and failures among clinical compounds tested to date. The gene expression of Viscient Bio's models is also well correlated with that seen in disease samples from patients. Though tested post-hoc, the results are not backfit, as the model was finalized before testing of any clinical compounds was conducted.\n\n\n\nLow approval rate\n\n\n\nAccording to the Biotechnology Innovation Organization's 2021 report, only 7.9% of drugs that enter clinical trials are approved for human use. Viscient Biosciences said it believes it can achieve a significantly better clinical translation rate using more relevant 3D human tissue models of disease, leading to more successes and lower drug development costs per approved drug. \n\n\n\nViscient Biosciences’ lead compound is expected to enter the clinic in 2024.