Development pipeline

Fibrinogen (BT-524)

Biotest's novel fibrinogen concentrate (BT-524) is purified from human plasma.

Fibrinogen is a plasmatic coagulation protein produced in the liver and is not only essential, but is also one of the most important factors of the clotting cascade. Upon conversion into fibrin it takes on a crucial role in clot formation and haemostasis. In case of fibrinogen deficiency the blood’s ability to form a clot is impaired, which leads to a greatly increased risk of critical bleeding and additionally to a delay in bleeding cessation.

In the case of severe congenital fibrinogen deficiency patients' ability to produce sufficient levels of functional fibrinogen is impaired or absent. These patients require frequent injections of fibrinogen concentrate. In acquired fibrinogen deficiency patients lose endogenous fibrinogen, which can lead to uncontrolled bleeding. A frequent cause is high blood loss during complex surgery but also as a result of severe traumatic injuries. In this case fibrinogen must be administered intravenously to stop the bleeding by increasing fibrinogen above the critical level.

Biotest's fibrinogen concentrate is currently being investigated clinically in a multinational phase I/III trial in patients with congenital fibrinogen deficiency. A Phase III study in acquired fibrinogen deficiency for patients with high blood loss is in preparation and is estimated to recruit the first patients at the end of 2017.

Press releases

Biotest proceeds into phase III programme in congenital...

01.12.2015,

/PRESS RELEASEBiotest proceeds into phase III programme in congenital fibrinogen deficiency- Fibrinogen concentrate shows good efficacy and safety profile based on preliminary data- Preliminary data o ... [More]

Clinical trials

Title

Indication

Status

 
Fibrinogen (Study 984) Congenital fibrinogen deficiency Study ongoing

A prospective, open-label, uncontrolled, single dose phase I/III study investigating pharmacokinetic properties, efficacy, safety, and tolerability of BT524 (fibrinogen concentrate from human plasma) in patients with congenital fibrinogen deficiency

Link clinicaltrials.gov
 
Fibrinogen (Study 995) Congenital fibrinogen deficiency Study ongoing

A randomized, active-controlled, multicenter, phase III study investigating efficacy and safety of intra-operative use of BT524 (human fibrinogen concentrate) in subjects undergoing major spine surgery (AdFIrst).

Clinicaltrialsregister.eu