Novo Nordisk has announced that clinical trials for their investigational subcutaneous therapy concizumab will resume after an approximate five month pause, initiated in March 2020 in response to non-fatal thrombotic events in three enrolled patients. Concizumab is developed using a synthetically produced (recombinant) antibody derived from a single cell clone, designed to be equally effective in individuals with hemophilia A and B, irrespective of inhibitor status.
The trials are part of an ongoing phase 3 program (explorer 6, 7 and 8), designed to investigate concizumab prophylaxis treatment in hemophilia A and B patients regardless of inhibitor status. According to a new press release, the trials are set to resume “as soon as local procedures allow,” with new safety measures and guidelines in place. These safety steps were informed by an analysis of all available data and agreed upon with U.S. Food and Drug Administration.
“I am pleased that we are able to safely restart the explorer trials. This emphasizes Novo Nordisk’s long-term dedication to the haemophilia community and our commitment to develop new subcutaneous prophylaxis options for all haemophilia patients,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk.
Source: Novo Nordisk press release dated August 13, 2020