Assessment of corrected JT-peak (JTpc) and Tpeak-to-Tend (TpTec) as proarrhythmia biomarkers in non-human primates: Outcome from a HESI consortium

The HESI Cardiac Safety Committee has published a new study in the Journal of Pharmacological and Toxicological Methods exploring the use of corrected JT-peak (JTpc) and Tpeak-to-Tend (TpTec) intervals as potential biomarkers for assessing drug-induced proarrhythmia risk in nonclinical species. This collaborative research, conducted by a multi-stakeholder consortium, provides critical insights into the translational value of these ECG sub-intervals in evaluating cardiac safety and correlates to the work done by FDA scientists on clinical ECGS (Vicente et al., 2018 doi10.1002/cpt.1303).

Understanding how these biomarkers perform in preclinical models is essential for improving the prediction of cardiac risks in humans and refining regulatory safety assessments. The findings highlight the complexities of translating nonclinical data into clinical outcomes and underscore the need for continued innovation in cardiac safety testing.

Read the full study here:

Assessment of corrected JT-peak (JTpc) and Tpeak-to-Tend (TpTec) as proarrhythmia biomarkers in non-human primates: Outcome from a HESI consortium. Boulay et al., 2024. Journal of Pharmacological and Toxicological Methods. https://doi.org/10.1016/j.vascn.2024.107543