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 investigated clinically in a multinational phase I/III trial in patients with congenital fibrinogen deficiency. The trial data are currently being evaluated. For the acquired fibrinogen deficiency Biotest is conducting a Phase III study (AdFirst: Adjusted Fibrinogen Replacement Strategy) in several European countries in patients with high blood loss during spine surgery or abdominal surgery for treatment of pseudomyxoma peritonei (PMP).

Press releases

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 Study 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 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 major spinal or abdominal surgery (AdFirst).

Link clinicaltrials.gov