PRESS RELEASE

Biotest achieves important milestone in phase III trial in acquired fibrinogen deficiency

• Successful interim analysis performed with 80% of evaluable patients
• Originally planned number of patients confirmed
• Completion of trial expected in 2023
• AdFIrst trial will be the basis for approval of Biotest’s human fibrinogen concentrate BT524 in patients with uncontrolled severe haemorrhage in acquired hyperfibrinogenaemia (blood loss caused by major surgery or trauma).

Dreieich, 30 March 2023. Biotest AG today announced that the last planned interim analysis in its phase III trial AdFIrst (Adjusted Fibrinogen Replacement Strategy) has been successfully completed.

The AdFIrst trial is a prospective, randomised, active-controlled, multicentre phase III trial investigating the efficacy and safety of Biotest’s human fibrinogen concentrate BT524 in the treatment of severe blood loss in patients undergoing planned spinal or abdominal surgery. The efficacy and tolerability of BT524 are being investigated in the AdFIrst trial in comparison to standard therapy of the respective centres, fresh frozen plasma or cryoprecipitate.

The aim of the final interim analysis was to assess for the potential of futility and to confirm the final sample size.

The AdFIrst trial will now continue as planned without modifications to full enrolment of 200 evaluable patients. The decision follows the recommendation of an independent statistician and is based on the successful completion of the planned final interim analysis after 160 treated patients were evaluable and analysed. Biotest expects completion of the trial in 2023.

In addition, in December 2022, based on the review of the safety data available at that time, an independent Data Safety Monitoring Board recommended the continuation of the trial without further adjustment.

“We are encouraged by the results of the last interim analysis of the AdFIrst phase III trial. All of us at Biotest are now intensely focused on completing the final portion of patient enrolment in the AdFIrst trial,” said Heike Böhm, Director Clinical Strategy & Development at Biotest AG. “We look forward to making fibrinogen treatment available for a broad patient population.”

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, as part of the Grifols Group, would like to play a leading role in the future.

The results of Biotest’s two clinical trials, the AdFIrst trial 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. Biotest aims to obtain market authorisation in Europe followed by the US.

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 planned spinal or 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 2,200 employees worldwide. The ordinary and preference shares of Biotest AG are listed in the Prime Standard on the German stock exchange. Since May 2022, Biotest is part of the Grifols Group, Barcelona, Spain (www.grifols.com).

IR contact

Dr Monika Buttkereit

Phone: +49-6103-801-4406
Mail: [email protected]

PR contact

Dirk Neumüller

Phone: +49-6103-801-269
Mail: [email protected]

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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.