First patient with aquired fibrinogen deficiency treated in clinical phase III study of Biotest AG
- Important milestone reached in the clinical development programme of fibrinogen concentrate
- Phase III study in acquired fibrinogen deficiency approved by European regulatory authorities and ethics committees
- The results will be the basis for marketing authorisation in Europe
Dreieich, 15 March 2018. Biotest AG today announces that the first patient in the pivotal phase III study in patients with acquired fibrinogen deficiency (study no. 995) has been treated.
The ADFIRST (Adjusted Fibrinogen Replacement Strategy) study recruits patients who lose the body's own coagulation factor fibrinogen due to major blood loss during a planned spinal surgery. To compensate this fibrinogen deficiency and to halt such bleedings effectively Biotest has developed the fibrinogen concentrate BT524. In ADFIRST, the efficacy and safety of BT524 are being studied and compared with the standard therapy fresh frozen plasma.
The study design was coordinated with the European Medicines Agency (EMA) and the study has been approved by European authorities and ethics committees. It is planned to conduct the study in about 200 patients in a total of 15 study sites in Germany, Spain, Belgium, Switzerland and Poland.
With the start of the ADFIRST study in aquired fibrinogen deficiency Biotest is further expanding the development programme of its fibrinogen concentrate BT524. The ongoing phase I/III study no. 984 in patients with congenital fibrinogen deficiency is proceeding as planned. Based on the first preliminary results, the EMA has agreed on the paediatric investigation plan for treatment of children below 6 years in this study.
The results of both studies will serve as a basis for the marketing authorisation of fibrinogen concentrate BT524 for treatment of patients with congenital and acquired fibrinogen deficiency.
About fibrinogen and fibrinogen deficiency
Fibrinogen is a blood clotting factor that is produced in the liver. It plays a key role in primary haemostasis (stopping blood loss from bleeding wounds) and wound healing. In case of a lack or shortage of fibrinogen blood's ability to clot is impaired which leads to a much greater risk of bleeding and delayed haemostasis. To date, these patients have been treated mainly with fresh frozen plasma (FFP), but this contains variable amounts of fibrinogen and must be thawed prior to treatment. The defined amount of fibrinogen in the fibrinogen concentrate now allows a tailor-made, patient specific and highly effective therapy.
About Biotest's fibrinogen concentrate
The newly developed manufacturing process of the fibrinogen concentrate leads to high-purity fibrinogen with a defined concentration, high level of viral safety and good solubility.
About study no. 995 /
The ADFIRST study is a prospective, active-controlled, multicentre phase III study investigating the efficacy and safety of the fibrinogen concentrate BT524 in patients with acquired fibrinogen deficiency. Patients who have high blood loss during elective spinal surgery are randomised 1:1 to treatment with BT524 or FFP. To evaluate efficacy, further blood loss is then compared between the two treatments. Further information about the study design can be found at www.clinicaltrialsregister.eu (EudraCT number: 2017-001163-20).
Biotest is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition, Biotest develops monoclonal antibodies in the indications of cancer of plasma cells and systemic lupus erythematosus which are produced by recombinant technologies. Biotest has more than 1,600 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
Dr. Monika Buttkereit
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com
Ordinary shares: securities' ID No. 522720; ISIN DE0005227201
Preference shares: securities' ID No. 522723; ISIN DE0005227235
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This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.
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