The FDA has entered into an agreement to use the Entelos Cardiovascular PhysioLab to assess cardiovascular safety and efficacy of a specific drug class and a set of drugs within that class. The compound class and specific set of drugs were not disclosed.
The Foster City, Calif.-based company said its Cardiovascular PhysioLab platform is a computer simulation of cholesterol regulation, atherogenesis and cardiovascular risk. It has been used by Entelos for pharmaceutical customers to simulate and predict the effects of drugs in patients and patient populations, evaluate new drug targets, test combination therapies, identify and interpret biomarker patterns and predict a drug’s long-term biological effects.
“Having information that may be predictive of likely adverse events or that can help to explain the biological mechanisms leading to adverse events in certain patient types could be extremely valuable. This project will thus test the predictive value of using a dynamic, mechanistic computer model of cardiovascular disease processes and a large virtual patient population for detecting rare adverse events,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research.
Entelos said that a range of ‘virtual patients’ will be generated using its cardiovascular platform and used for simulations to test the cardiovascular safety and efficacy of multiple drugs. Results will be compared to existing clinical trial data collected by the FDA from multiple drug sponsors.