Thrasos Therapeutics, a biotherapeutics company focused on delivering new solutions for kidney disease, today presented preclinical results showing that its lead development compound THR-184 can effectively protect against loss of kidney function following acute ischemic injury in rat. Results of the studies were presented at the 51st European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Congress taking place in Amsterdam, The Netherlands.
THR-184 is a small proprietary peptide that acts on the BMP/Smad pathway. It is in development for the prevention of and treatment of acute kidney injury (AKI). Results from a broad set of preclinical studies, as well as two phase 1 clinical trials in which THR-184 was safe and well-tolerated, led to the design and initiation of a major phase 2 clinical trial. That trial is now being conducted in Canada and the United States and is focused on the prevention of AKI in patients undergoing cardiac surgery. THR-184 was granted Fast Track designation for this indication by the U.S. Food and Drug Administration (FDA) in February of 2014.
In the studies presented today, THR-184 was shown to significantly decrease the severity of AKI when administered in an animal model of acute renal ischemia. THR-184 was administered prior to the injury, following the injury, and both prior to and following the injury. The highest level of efficacy was seen when THR-184 was administered both prior to and following the injury.
"THR-184 has been studied extensively in my lab and has demonstrated strong and consistent performance in our animal model of AKI," said Bruce A. Molitoris, M.D., Professor of Medicine in the Division of Nephrology at Indiana University. "I am looking forward to seeing the results of the large phase 2 trial currently being conducted by Thrasos."
"This critical work, so carefully executed by Dr. Molitoris and his team has provided us with the foundation for our clinical program," said Richard Andrews, President and Chief Executive Officer of Thrasos. "Based on the data from these studies, we have been able to progress our development program through safety and toxicology testing, two Phase 1 studies, and most recently into a major Phase 2 clinical trial. Our hope is that following continued testing THR-184 can make a major contribution to the prevention and treatment of AKI."