FDA Awards AnaBios Grant to Further Develop Preclinical Assay Using Human Primary Cardiomyocytes
SAN DIEGO, Sept. 17, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has named AnaBios the recipient of a grant to further develop its unique drug discovery platform utilizing muscle cells from the human heart (cardiomyocytes). Funds from the grant will be used to develop a preclinical biomarker to identify the pro-arrhythmia risk of potential drugs based on contractility measurements in human adult primary cardiomyocytes. AnaBios' cardiomyocyte research has yielded highly translational information about cellular properties and drug-induced variations in cardiac function.
"AnaBios is honored to receive this grant from the FDA for this critical project related to cardiac safety," said Dr. Najah Abi-Gerges, Vice President of Research & 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, the FDA and 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 pro-arrhythmia risk.
The correlation between electrical (action potential) and mechanical (contraction) abnormalities is a consequence of the tight functional coupling between these two processes in adult cardiac cells and tissues. As a result, drug-induced ventricular repolarization irregularities may also lead to severe contractility abnormalities. AnaBios' human cardiomyocyte contractility model simultaneously evaluates pro-arrhythmia 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 pro-arrhythmia risk in advance of clinical studies. The outcome of this research project should provide critical information for drug developers and regulators with respect to the cardiac risk of drugs at the preclinical stages of drug development.
Funding for this project was made possible, in part, by the FDA through grant U01FD006879. Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.
About AnaBios
Located in San Diego, California, AnaBios aims to establish the safety and efficacy of novel compounds through its advanced, human-focused translational technologies. AnaBios primarily focuses on areas of high, unmet medical need, including cardiac disease, pain and itch. In addition to working with Fortune 500 biotech companies, CROs and academia, AnaBios drives an internal drug discovery platform via in-licensed programs from partners in the pharmaceutical industry. For more information about AnaBios, visit http://www.anabios.com.
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SOURCE AnaBios
