SAN DIEGO, CA – January 22, 2018 – First-of-its-kind preclinical ex-vivo human cardiac research conducted by AnaBios and Amgen, published today in the journal Frontiers in Physiology, demonstrates that isolated human heart-based model, combined with the integrated analysis using newly-developed pro-arrhythmic score, can differentiate between pro-arrhythmic and non-pro-arrhythmic compounds and has a greater predictivity when compared to models derived from human stem cells.
“Our innovative translational approaches enable human-focused drug discovery and help ensure the safety and efficacy of new treatments,” said Dr. Andre Ghetti, Chief Executive Officer of AnaBios.
“Data from this research demonstrates that isolated adult human ventricular tissue enables the generation of reliable and predictive data for human-focused cardiac safety assessment at early stages in drug discovery, provides a good opportunity to prioritize compounds and eliminates the potential for cross-species differences,” said Dr. Najah Abi-Gerges, Vice President of Research and Development at AnaBios.
Cardiac safety remains the leading cause of drug development discontinuation. Strategies to improve cardiac safety at the preclinical stage have thus far shown limited predictivity and have stimulated a quest to improve drug-induced cardiotoxicity assessment with human-relevant models.
For this research, human ventricular trabeculae isolated from ethically-consented organ donors were used to assess the effects of 13 blinded clinical reference drugs on cardiac action potential. When the pro-arrhythmia risk was evaluated at tenfold of the effective therapeutic plasma concentration of each drug, the pro-arrhythmia score had high sensitivity and specificity. This high predictivity supports the translational potential of the new model and indicates it could become a reliable component of preclinical risk assessment.