Novo Nordisk is set to resume the Phase III explorer 6, 7 and 8 clinical trials of concizumab as a prophylaxis treatment in patients with haemophilia A and B, with or without inhibitors.
The studies were temporarily stopped in March this year after non-fatal thrombotic events were reported in three participants.
Novo Nordisk has collaborated with relevant authorities to determine a new approach for further development of the drug.
All available data was analysed and new safety measures and guidelines have been agreed with the US Food and Drug Administration (FDA).
Novo Nordisk executive vice-president and chief scientific officer Mads Krogsgaard Thomsen said: “I am pleased that we are able to safely restart the explorer trials. This emphasises Novo Nordisk’s long-term dedication to the haemophilia community and our commitment to develop new subcutaneous prophylaxis options for all haemophilia patients.”
Concizumab is a monoclonal antibody designed to target the tissue factor pathway inhibitor (TFPI). The drug is intended to prevent bleeding in haemophilia A and B patients after subcutaneous administration.
Novo Nordisk launched the Phase III ‘explorer7’ trial of the drug in October last year in patients with haemophilia A or B with inhibitors towards FVIII or FIX.
The trial is intended to assess the safety and efficacy of a once-daily prophylactic subcutaneous dose of the drug given in a pen device to decrease the number of bleeds.
Meanwhile, the ‘explorer8’ study was started in November last year in haemophilia A or B patients without inhibitors. The trials are set to recruit a total of around 293 patients across 32 countries.
In September last year, Novo Nordisk reported positive data from the Phase II REAL 3 trial of somapacitan in children with growth hormone deficiency (GHD).