Critical Path Institute Secures Regulatory Support for Skeletal Muscle Safety Biomarkers

FDA and EMA Letters of Support Suggest Valuable Research Potential

TUCSON, Ariz.--()--The Critical Path Institute (C-Path) announced today that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued Biomarker Letters of Support for four skeletal muscle safety biomarkers identified and evaluated by C-Path’s Predictive Safety Testing Consortium (PSTC)’s Skeletal Myopathy Working Group. This is the second time the two agencies have provided a Biomarker Letter of Support to PSTC in the past six months, following FDA and EMA support for the kidney safety biomarkers osteopontin (OPN) and neutrophil gelatinase-associated lipocalin (NGAL).

"This Letter of Support intends to encourage scientists to collect data from exploratory studies, which may lead to qualification of these types of biomarkers," said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. "We are optimistic about how this effort will further advance biomarker development."

The skeletal safety biomarkers – myosin light chain (Myl3), skeletal muscle troponin I (sTnI), fatty acid binding protein 3 (FABP3), and creatine kinase muscle type (CK-M, the homodimer CK-MM) – are proteins that can be measured in plasma or serum. Higher levels of these biomarkers could indicate that skeletal muscle injury is occurring.

"The support from FDA and EMA of these skeletal muscle safety biomarkers as potential indicators for drug safety is an encouraging development in the PSTC’s larger mission of facilitating scientific validation and regulatory qualification of novel safety biomarkers," says C-Path President and CEO Martha A. Brumfield, PhD.

Each agency’s letter is intended to encourage the biomarkers' use in nonclinical and exploratory clinical studies as markers of skeletal muscle injury. These letters are posted on the FDA DDT website and the EMA website, and can be accessed via the C-Path PSTC website, along with a summary data package describing the studies that support the use of these kidney safety biomarkers.

About the Critical Path Institute

The Critical Path Institute (C-Path) is an independent, non-profit organization established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and the FDA. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. For more information, visit www.c-path.org.

Contacts

Critical Path Institute
Kissy Black, 615-298-1144
kissyblack@lotosnile.com

Contacts

Critical Path Institute
Kissy Black, 615-298-1144
kissyblack@lotosnile.com