Novo Nordisk is set to resume the phase 3 clinical trials of concizumab in haemophilia A and B, with or without inhibitors, following a previous safety scare.
Back in March, Novo paused the trials due to the occurrence of non-fatal thrombotic events in three patients enrolled in the ongoing phase 3 programme.
Novo worked with the relevant authorities to identify a new path forward for the drug, which includes new safety measures and guidelines based all available data.
In October 2019, Novo started the explorer7 phase 3 study of concizumab in patients with haemophilia A or B with inhibitors towards FVIII or FIX.
A parallel phase 3 trials in haemophilia A or B patients without inhibitors was initiated in November 2019. The trials are expect to enrol approximately 293 patients from 32 countries.
“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,” said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk.
Concizumab is designed to target a natural anticoagulant protein named tissue factor pathway inhibitor (TFPI), which is indicated as a cause of haemophilia.