Novo Nordisk recently announced that they have “paused” three clinical trials for their investigational subcutaneous therapy concizumab. The therapy is developed using a synthetically produced (recombinant) antibody derived from a single cell clone, which is designed to be equally effective in individuals with hemophilia A and B, irrespective of inhibitor status.
The paused trials include two from a phase 3 program (explorer7 and 8) and one in a phase 2 program (explorer5). All three clinical trials were investigating concizumab prophylaxis treatment in hemophilia A and B patients regardless of inhibitor status. The trials were put on hold in response to non-fatal thrombotic events in three patients enrolled in the ongoing phase 3 program. According to a new press release, Novo Nordisk and an independent Data Monitoring Committee, are currently assessing the “relevance of the events to the continuation of the program.” In the meantime, patients currently participating in the trials will cease treatment with concizumab while no additional patients will be recruited.
“While it is disappointing to pause the trials, patient safety is of utmost importance to Novo Nordisk – both for those taking part in our clinical trials and those who use our products on a daily basis” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “Together with relevant authorities, we will now carefully evaluate all available data and decide how to best move forward”.
Source: Novo Nordisk press release dated March 16, 2020