Countermeasure Development: First Ever FDA Qualification of Clinical Safety Biomarker

The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium and the Critical Path Institute (C-Path) Predictive Safety Testing Consortium (PSTC) have received the first ever qualification of a clinical safety biomarker awarded by the U.S. Food and Drug Administration (FDA).

This significant achievement will improve the detection of drug-induced kidney injury in early phase drug development, helping to improve the development of safe and effective medical countermeasures and disease therapeutics where concern has been raised that an investigational drug may cause kidney injury.

This qualification applies to a single composite measure of six urine biomarkers, to be used in conjunction with traditional measures of kidney function. It measures the change over time of the urine biomarkers that the team selected for tracking acute damage to the kidney tubules.

The qualification submission to the FDA included analyses of data collected from a Normal Healthy Volunteer Study funded by the PSTC and a collaborative Harvard-Merck Study of cancer patients with mesothelioma treated with cisplatin, a common chemotherapy drug known to cause kidney injury.

In achieving this milestone, PSTC, C-Path’s longest running consortium, celebrates the successful translation of its preclinical biomarkers previously qualified for use in animal studies, for use now in Phase 1 clinical trials. “The acceptance of these clinical safety biomarkers marks our first successful translation of biomarkers qualified for preclinical use to use in clinical drug development. This is a major step forward in our efforts to accelerate the development of safer medicines for patients in need,” said Dr. John-Michael Sauer, Executive Director, PSTC.

Funding for this project was provided by Amgen, Inc., AstraZeneca, C-Path, Johnson & Johnson, Eli Lilly and Company, Merck and Pfizer. This achievement was made possible by the collective efforts of the Clinical Evaluation and Qualification of Translational Kidney Safety Biomarkers Project (Kidney Safety Project) team. Its members include the FNIH, C-Path’s PSTC Nephrotoxicity Working Group, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), academia and industry, with advice from the FDA.

Source: C-Path