Biotest achieves significant milestone by completing phase I/III clinical trial with fibrinogen

Largest clinical trial in congenital fibrinogen deficiency worldwide

First results confirm expected efficacy and safety in adults and children

Results are basis for the approval of this pharmaceutical in within the scope of the expansion project Biotest Next Level

DREIEICH, Germany I May 26, 2020 I Biotest today announced the completion of the clinical trial 984. In the phase I/III study, patients with congenital fibrinogen deficiency were treated with the fibrinogen concentrate (BT524) developed by Biotest in the case of acute bleeding or as prophylactic treatment before surgery. These patients are unable to produce functional fibrinogen themselves, or only insufficiently and are therefore dependent on the administration of external fibrinogen.

The prospective, open, multicentre phase I/III study investigated the pharmacokinetic properties, efficacy and safety of fibrinogen concentrate in adults and children with congenital fibrinogen deficiency. With well over 100 bleeding events treated in a total amount of 35 patients of all age groups, the study is currently the largest prospective clinical trial in this indication. The evaluation of the extensive data is currently underway. First results confirm the high expectations regarding efficacy and safety and form the basis for the approval of the fibrinogen concentrate purified from human plasma.

"We are very pleased to have reached this important milestone in the development of our fibrinogen concentrate. The final results are expected at the end of the 4th quarter of 2020. In addition to IgG Next Generation, this compound is another product manufactured in the new production facility "Biotest Next Level", explains Dr Andrea Wartenberg-Demand, Vice President Clinical Research and Development.

In addition to congenital fibrinogen deficiency, there is the indication of acquired fibrinogen deficiency. Biotest is also testing the fibrinogen concentrate in this indication in the phase III trial called "ADFIRST". Here, the inclusion of the patients continues. The results of both studies are to serve as the basis for the approval of fibrinogen concentrate for the treatment of patients with congenital and acquired fibrinogen deficiency.

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).

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

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 care medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumin based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. Biotest has more than 1,800 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

SOURCE: Biotest

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