FDA has awarded a grant to AnaBios, San Diego, for further development of a preclinical biomarker that uses contractility measurements in human adult primary cardiac muscle cells to identify the proarrhythmia risk of potential drugs. AnaBios’ cardiomyocyte research has yielded translational information about cellular properties and drug-induced variations in cardiac function.
Najah Abi-Gerges, MD, AnaBios.
“AnaBios is honored to receive this grant from FDA for this critical project related to cardiac safety,” says Najah Abi-Gerges, MD, vice president of research and development at AnaBios. “Because our research uses human heart cells derived from organ donors, our human cardiac platform provides direct translation to human clinical outcomes. This research project will help us further develop this critical tool for assessing cardiac safety risk in preclinical drug discovery.”
Current strategies for cardiac safety evaluation of drugs have shown significant limitations. Over the past several years, FDA and the pharmaceutical industry have promoted initiatives to develop more predictive, human-relevant preclinical platforms to solve this problem. In this context, AnaBios established an adult human primary cardiomyocyte contractility model that has the potential to predict drug-induced inotropic and proarrhythmia risk.
In adult cardiac cells and tissues, the correlation between electrical (action potential) and mechanical (contraction) abnormalities is a consequence of the tight functional coupling between these two processes. As a result, drug-induced ventricular repolarization irregularities may also lead to severe contractility abnormalities. AnaBios’ human cardiomyocyte contractility model simultaneously evaluates proarrhythmia risks from the measurement of drug-induced changes in several parameters derived from the kinetics of the contractility transient.
AnaBios plans to further combine the parameters into a single biomarker that can be used to predict proarrhythmia risk in advance of clinical studies. The outcome of the FDA-funded research project should provide critical information for drug developers and regulators about the cardiac risk of drugs at the preclinical stages of their development.
For more information, visit AnaBios.
