DREIEICH, Germany I February 14, 2024 I Biotest announced today that the AdFIrst (Adjusted FIbrinogen replacement strategy) phase III trial met its primary endpoint, demonstrating that Fibrinogen concentrate is non-inferior to standard of care in reducing intraoperative blood loss in patients with acquired fibrinogen deficiency undergoing planned major spinal or abdominal surgery. Mean blood loss measured in the two treatment groups were 1,444 mL in the Fibrinogen concentrate group versus 1,735 mL in the standard of care group, resulting in a reduction of blood loss of 291 mL in patients treated with fibrinogen concentrate. The AdFIrst trial was a prospective, randomised, active-controlled, multicentre phase III trial involving 222 patients undergoing elective spine or abdominal surgery. The main purpose of this phase III trial was to demonstrate that Fibrinogen concentrate improves clotting function and reduces blood loss in the management of severe haemorrhage as effectively as standard of care. The efficacy and safety of Fibrinogen concentrate was compared with the centres’ standard of care, either fresh frozen plasma or cryoprecipitate. “We are very pleased to have successfully completed this clinical trial. Our focus is now on preparing the marketing authorization applications,” said Dr Silke Aigner, Senior Director Clinical Strategy & Development at Biotest AG. “There is a high medical need for additional fibrinogen concentrates to ensure availability of fibrinogen for more patients in this severe medical situation.” As part of the Grifols GroupGrifols Group, Biotest intends to play a leading role in making this therapy available in a broader patient population. Compared with congenital fibrinogen deficiency, where efficacy has been demonstrated in an earlier trial, the market size for the treatment of acquired fibrinogen deficiency is many times larger. There is a worldwide market potential of USD 800 million. The market in the US, in particular, has great development potential, as therapy with fibrinogen concentrate is not established there. Detailed results of the trial will be presented later this year.
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 AdFIrst trial no. 995
The AdFIrst trial was a prospective, active-controlled, multicentre phase III trial investigating the efficacy and safety of the Fibrinogen concentrate (BT524) in patients with acquired fibrinogen deficiency. Patients who had high blood loss during planned spinal or abdominal surgery were randomized 1:1 to treatment with Fibrinogen concentrate (BT524) or fresh frozen plasma (FFP)/Cryoprecipitate. To evaluate the efficacy of BT524, blood loss was compared between the both treatment options. Further information about the trial design can be found at www.clinicaltrialsregister.eu (EudraCT number: 2017-001163-20). 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. The fibrinogen concentrate alternatives fresh frozen plasma (FFP) and cryoprecipitate contain variable amounts of fibrinogen and must be thawed prior to treatment. The defined amount of fibrinogen in the fibrinogen concentrate will allow a tailor-made, patient specific and highly effective therapy. Biotest is a provider of biological therapeutics derived from human plasma. 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 2,400 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 has been a part of the Grifols Group, based in Barcelona, Spain (www.grifols.com).