DGAP-News: Biotest AG: Biotest achieves important milestone in Phase III study in acquired fibrinogen deficiency

PRESS RELEASE

Biotest achieves important milestone in Phase III study in acquired fibrinogen deficiency

• Successful interim analysis after 120 patients
• Number of patients originally planned for study confirmed
• Results are the basis for approval in patients with severe blood loss after major surgery

Dreieich, 10 June 2022. Biotest AG announced today that the planned interim analysis of the phase III AdFIrst (Adjusted Fibrinogen Replacement Strategy) trial with Fibrinogen in patients with acquired fibrinogen deficiency was successful.

The AdFIrst study is a prospective, randomised, active-controlled, multicentre phase III trial investigating the efficacy and safety of fibrinogen in the treatment of severe blood loss in patients undergoing planned spinal or abdominal surgery. The efficacy and tolerability of fibrinogen are being tested in the AdFIrst study in comparison to standard therapy consisting of two blood products, fresh frozen plasma or cryoprecipitate.

As a result of the interim analysis at the beginning of June, an independent statistician recommended continuing the study with the originally planned number of patients.

Biotest AG has decided to follow this recommendation and to continue the trial according to the original assumption without adjusting the patient numbers. According to the trial protocol a further interim analysis to confirm patient numbers is scheduled, once 80% of the planned patients have been treated and evaluated. The final results of the trial are expected in spring 2023. The development of Fibrinogen is, therefore, on schedule.

"The recommendation of the independent statistician is excellent news for us and confirms our plan to develop Fibrinogen not only for congenital but also for acquired fibrinogen deficiency" underlines Dr Andrea Wartenberg-Demand, Vice President Clinical Strategy & Development at Biotest AG.

Worldwide, there are only two other fibrinogen concentrates approved for acquired fibrinogen deficiency, but they are not available globally. Compared to congenital fibrinogen deficiency, the market size for the treatment of acquired fibrinogen deficiency is many times larger. There is a worldwide market potential of 400-800 million USD. In particular, there is a large development potential for the market in the USA, as therapy with fibrinogen concentrate is only slowly becoming established there. For this, Biotest would like to play a leading role in the future.

The results of two Biotest clinical trials, the AdFIrst study and the completed phase I/III trial in patients with congenital fibrinogen deficiency, will serve as the basis for the approval of fibrinogen concentrate BT524 for the treatment of patients with congenital and acquired fibrinogen deficiency. Biotests aim is to get an approval in Europe, followed by the US approval.

About Biotests 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 AdFIrst
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 planned spinal and abdominal surgery are randomised 1:1 to treatment with BT524 or FFP/Cryoprecipitate. To evaluate the efficacy, further blood loss is compared between the both treatment options. 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 2,000 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange.

IR contact
Dr Monika Buttkereit
Phone: +49-6103-801-4406
Mail: ir@biotest.com

PR contact
Dirk Neumüller
Phone: +49-6103-801-269
Mail: pr@biotest.com

Biotest AG, Landsteinerstr. 5, 63303 Dreieich, Germany, www.biotest.com

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Disclaimer
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.