Novo Nordisk has paused the Phase III explorer7 and explorer8 trials for haemophilia drug concizumab, due to non-fatal thrombotic events, the company says.
The Danish drugmaker has confirmed that no additional patients will be recruited, and further treatment of patients currently enrolled in the trials with concizumab will cease.
The studies, in addition to the the Phase II explorer5 trial, were evaluating prophylactic use of concizumab in haemophilia A and B patients regardless of inhibitor status.
The company is citing the occurrence of non-fatal thrombotic events in three patients enrolled in the late-stage programme as reason to suspend the trial, with an independent data monitoring committee adding it is in the process of "assessing the relevance of the events to the continuation of the programme and no conclusions have yet been made.”
Novo initiated the explorer7 Phase III trial last October, establish the safety and efficacy of once-daily prophylactic subcutaneous concizumab delivered in a pen device to reduce the number of bleeds.
A parallel Phase III trial in haemophilia A or B patients without inhibitors, explorer8, was then initiated in November 2019.
Haemophilia is a mostly inherited genetic disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding. This results in people bleeding for a longer time after an injury, easy bruising, and an increased risk of bleeding inside joints or the brain.
