The Medicines Company has voluntarily discontinued its Phase 2b dose-ranging study of MDCO-2010, a serine protease inhibitor that was being developed as an intravenous antifibrinolytic drug for the reduction of blood loss during surgery.
The company had decided to terminate the trial due to the serious unexpected patient safety issues during the trial, which till now recruited 44 of a planned 90 patients in the first stage of the study.
The company had determined not only to end the trial but also stop further development of MDCO-2010 due to evidence of risk to patients even though the cause of the safety issues and any potential link to the study drug are still under analysis.
An in-depth assessment of the entire patient data from the study and any information related to cause of risk is ongoing, according to The Medicines Company.
The dose-ranging study was the only clinical trial of MDCO-2010 currently underway, while a previous Phase 2a trial met its clinical objectives in late 2011.
The Medicines Company informed the German and Switzerland regulatory agencies, where patients were enrolled onto the study, in addition to Health Canada and the US Food and Drug Administration where future patient enrolment was planned.
The company claimed that the compound has demonstrated a favourable pharmacokinetic profile for the surgical setting with a rapid onset and offset of effect, due to its short half life, in preclinical studies.
