Novo Nordisk announced that two clinical trials in the concizumab phase III programme (explorer7 and 8) and one clinical trial in the phase II programme (explorer5) have been paused. The three clinical trials were investigating concizumab prophylaxis treatment in haemophilia A and B patients regardless of inhibitor status. Consequently, no additional patients will be recruited, and further treatment of patients currently enrolled in the trials with concizumab will cease.
The decision is a result of the occurrence of non-fatal thrombotic events in three patients enrolled in the ongoing phase III programme. Novo Nordisk and an independent Data Monitoring Committee are currently assessing the relevance of the events to the continuation of the programme and no conclusions have yet been made.