FDA and CN Bio co-publish paper on drug safety evaluation technology 14th January 2021
Single and multi organ-on-chip microphysiological systems (MPS) developer CN Bio and the FDA have co-published a peer-reviewed research paper demonstrating that data derived using CN Bio’s proprietary PhysioMimix system is appropriate for use in drug safety and metabolism applications. CN Bio states that liver toxicity is a major safety concern during drug discovery and development, with the potential to terminate clinical trials and result in expensive programme failures and it is estimated that companies could save 26% of drug discovery costs through the incorporation of MPS technologies by generating human-relevant data that better predicts clinical outcomes. The new co-publication with the FDA provides evidence of the advantage of MPS over standard techniques and clear criteria to ensure robust operation, both critical factors to enable the fast-track adoption of these technologies. Scientists at the FDA have demonstrated that CN Bio’s PhysioMimix MPS technology accurately models drug metabolism and detects compounds known to be toxic to humans. Markers of liver function were used to evidence the longevity, reliability, and reproducibility of the system.
CN Bio’s single and multi-organ MPS enable researchers to better replicate the micro-environments, cell-cell interactions and biological processes that occur in vivo, opening new possibilities for the preclinical evaluation of medicines. The company says that confirmation by the FDA that the interaction between inflammation and liver toxicity can be observed in the system highlights the complexity with which human biology can now be recapitulated and that the new publication adds to the body of evidence demonstrating how PhysioMimix technology can rapidly generate human-relevant, robust data that is clinically translatable and predictive, facilitating more insightful, accurate and cost-effective drug development for improved clinical success.
Footnote: Characterizing the Reproducibility in Using a Liver Microphysiological System for Assaying Drug Toxicity, Metabolism and Accumulation’, Clinical and Translational Science, https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.12969