Biotest AG: Biotest achieves important milestone in Phase III study in acquired fibrinogen deficiency
News: Biotest AG / Key word(s): Research Update
Biotest achieves important milestone in Phase III study in acquired fibrinogen deficiency
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. Biotest’s aim is to get an approval in Europe, followed by the US approval.
About Biotest’s fibrinogen concentrate
About fibrinogen and fibrinogen deficiency
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