TransBioLine work package 3 (WP3; drug-induced pancreatic injury; DIPI) applauds the recent Letter of Support issued by the FDA for DIPI safety biomarkers to the Critical Path Institute’s Predictive Safety Testing Consortium (PSTC).
Within the main objectives of TransBioLine of identifying, evaluating and achieving regulatory qualification of safety biomarkers to be implemented in drug safety assessments, WP3 focuses on drug-induced pancreatic injury. WP3 preliminary results for both miRNA and protein safety biomarkers are promising and indicate their potential utility for use in Phase I clinical trials to assess the safety of drug candidates with a priori concerns for DIPI.
In 2020, WP3 received a positive response from the EMA Committee for Medicinal Products for Human use (CHMP) for their work developing DIPI safety biomarkers. Recently, the FDA issued a Letter of Support to PSTC, encouraging further early clinical studies and the voluntary and complementary use of a set of microRNA biomarkers to detect and monitor DIPI.
Four specific microRNA candidates were identified as translational safety biomarkers for DIPI by PSTC and encouraged by the FDA, to be used in Phase 1 clinical trials in combination with currently available standard biomarkers, providing means for a more sensitive and specific monitorability of acute pancreatitis during drug development.
TransBioLine’s WP3 work benefits greatly from the FDA endorsement for continued development of DIPI biomarkers and looks forward to sharing TransBioLine’s clinical study results with the FDA to further the growing knowledge base on these relevant and important safety biomarkers, supporting their formal qualification for implementation in Phase I clinical trials.
The identification and development of regulatory qualified safety biomarkers will facilitate safer evaluation of new and current therapies and ultimately result in improved Quality of Life for the broader society by the reduction of the severity and occurrence of drug-related toxicities.