Could kidney damage biomarkers speed drug development?

Drug-induced kidney injury is an important issue for patients, and current biomarkers can bring up false positives, causing drug developers to abandon projects too early. A new collaboration will focus on finding new biomarkers that will more accurately pinpoint the potential for drug-induced nephrotoxicity.

The collaboration is between the Biomarkers Consortium, created by the Foundation for the National Institutes of Health (FNIH) and the Predictive Safety Testing Consortium (PSTC), founded by the Critical Path Institute (C-Path). The partners will manage a two-year study focusing on biomarkers that could accurately and sensitively identify drug-induced kidney injury at an earlier stage. The study, at four sites in the U.S., will analyze blood and urine samples from patients already being treated by drugs known to cause kidney damage (the cancer chemotherapeutic cisplatin, and aminoglycoside antibiotics, often taken by people with cystic fibrosis).

"We need better ways of predicting potential kidney injury from new therapies early on in the development process," said Dr. Janet Woodcock, director of the Center for Drug Evaluation Research at the FDA.

Drug development is a high-risk business, with many drugs failing (expensively) in clinical trials. Creating sensitive and accurate tests based on biomarkers could not only help developers to make early go/no-go decisions based on adverse events, but also prevent potentially useful drugs, especially in areas of high unmet need, being trashed early in their development, speeding the route to market. They could also pinpoint when clinical trials should stop, before exposing trial volunteers to too much risk.

- see the release