More info. Currently, drug-induced muscle injury DIMI is monitored in clinical trials using blood creatine kinase CK and aspartate amino transferase AST enzymatic activity in study participants.
However, there is an unmet drug development need for new biomarkers since CK and AST lack the desired sensitivity and tissue specificity needed to optimize the identification of drug induced DIMI during clinical trials.
This panel is intended to aid in the detection of acute DIMI in phase 1 trials in healthy volunteers, in conjunction with AST and CK, when there is an a priori concern that a drug may cause skeletal muscle injury in humans. The FDA expressed support for the consortia's intent to pursue biomarker qualification for the DIMI biomarker panel and invited submission of a Qualification Plan -- the second stage in the BQP process that details additional clinical validation studies and analysis for the intended Context of Use COU.
Finding solutions for unmet needs in drug development is at the core of C-Path's mission.
Through collaboration across these consortia and their industry members, we are advancing qualification of this biomarker panel to provide drug developers with a novel tool for more accurately detecting DIMI during clinical trials. John-Michael Sauer, Ph. As part of the 21st Century Cures Act, passed into law in Decemberpublic-private partnerships consisting of government entities, including FDA, the biopharmaceutical industry, health care providers, academic researchers, and patient advocacy organizations have been encouraged to work together to foster innovation in development of new therapies by qualifying new drug development tools that can accelerate the process of making new therapies available to patients.
Critical Path Institute C-Path.
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