The Medicines Company has voluntarily discontinued its phase Iib, dose-ranging study of MDCO-2010, a serine protease inhibitor being developed to reduce blood loss during surgery. This action was taken in response to serious unexpected patient safety issues encountered during the trial, which so far had recruited 44 of a planned 90 patients in the first stage of the study.
While the cause of the safety issues and any potential link to the study drug are still under investigation, the company decided to end both the trial and further development of MDCO-2010 because of the evidence of risk to patients. The Company is conducting an in-depth assessment of all patient data from the study and any information related to drivers of risk. Once this evaluation is completed and reviewed with experts in the field, the findings will be published.
The company has informed regulatory agencies in Germany and in Switzerland, where patients had been enrolled into the study. In addition, the company has informed Health Canada and the FDA, since patient enrollment was planned in both countries. The company will work with regulatory authorities as further information becomes available.
The dose-ranging study was the only clinical trial of MDCO-2010 currently underway. A prior phase IIa trial met its clinical objectives, with results reported in October 2011.