BT-524 is a human fibrinogen concentrate purified from human plasma.
Fibrinogen is a plasma protein produced by the liver, which is an important component of blood clotting. A deficiency of autologous fibrinogen means that the blood’s ability to clot is impaired, which leads to a greatly increased risk of bleeding and additionally to a delay in bleeding cessation.
In the case of congenital fibrinogen deficiency patients can not produce sufficient or any fibrinogen. In acquired fibrinogen deficiency, on the other hand, patients lose fibrinogen because of heavy bleeding, for example due to severe injuries and surgery. In both cases, fibrinogen must be supplied again to stop bleeding.
The fibrinogen (BT-524) developed by Biotest is currently being investigated clinically in a multinational phase I/III trial in patients with congenital fibrinogen deficiency.