Development pipeline

Fibrinogen (BT-524)

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, leading 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 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 has been clinically tested in a multinational phase I/III study in patients with congenital fibrinogen deficiency. For acquired fibrinogen deficiency, Biotest has recently completed a Phase III clinical trial (AdFirst: Adjusted Fibrinogen Replacement Strategy) in several European countries, enrolling patients undergoing planned major spinal or abdominal surgery. Based on the results of the two clinical trials, Biotest is going to file for marketing authorization of fibrinogen concentrate for the treatment of patients with congenital and acquired fibrinogen deficiency. 

Press releases

Biotest successfully meets primary endpoint in phase II...

14.02.2024,

14.02.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The EQS Distribution Se ... [More]

Biotest achieves important milestone in phase III trial...

30.03.2023,

30.03.2023 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The EQS Distribution Se ... [More]

Biotest accelerates fibrinogen phase III study with add...

07.04.2021,

07.04.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The DGAP Distribution Services incl ... [More]

Biotest achieves significant milestone by completing ph...

26.05.2020,

26.05.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.The DGAP Distribution Services incl ... [More]

Biotest generates revenues of EUR 377.8 million in the ...

14.11.2017,

Biotest generates revenues of EUR 377.8 million in the first nine months 2017- Successful regulatory inspection and approval of Biotest Next Level in August- Paul-Ehrlich Institute approves Phase III ... [More]

Biotest proceeds into phase III programme in congenital...

01.12.2015,

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

Biotest starts clinical development programme of human ...

06.12.2012,

Biotest starts clinical development programme of human fibrinogen concentrate to treat serious, life-threatening bleeding - Approval of study protocol to conduct a phase I/II clinical trial - Treatmen ... [More]

Clinical trials

Title

Indication

Status

 
Fibrinogen (Study 984) Congenital fibrinogen deficiency Trial completed

A prospective, open-label, phase I/III study investigating pharmacokinetic properties of BT524 and efficacy and safety of BT524 in the treatment and prophylaxis of bleeding in patients with congenital fibrinogen deficiency.

Link clinicaltrials.gov
 
Fibrinogen (Study 995; AdFirst) Acquired fibrinogen deficiency Trial completed

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 major spinal or abdominal surgery (AdFirst).

Link clinicaltrialsregister.eu