On Monday Danish company Novo Nordisk announced it would stop treating patients enrolled in clinical trials evaluating an investigational hemophilia drug it developed after three of those receiving the drug reported “thrombotic events.”
Hemophilia, an inherited blood disorder, is characterized by low levels of proteins called clotting factors, which help patients’ blood to clot appropriately. Low levels of those proteins can lead to serious health problems when bleeding occurs. The drug maker, best known for its diabetes products, was testing the drug, concizumab, as a once-daily injection designed to reduce the number of bleeds in the patients receiving it.
Thrombosis is the medical term for the formation of a blood clot, which can lead to a number of health issues, including stroke, depending on where the clot forms. Novo Nordisk didn’t provide any further details as to the side effects the patients experienced except to say they were nonfatal. The company said the connection between the side effects that prompted it to stop the trials of concizumab and the drug wasn’t yet clear, and that an assessment of the data would determine whether the program could continue.
In the meantime, the company is halting recruitment for the trials—two Phase 3 studies and one Phase 2 study—and stopping treatment of the 109 patients currently receiving concizumab. The affected trials enrolled patients with the two most common forms of hemophilia, A and B, which are caused by a lack or decrease in different clotting factors.