EQS-News

Biotest successfully meets primary endpoint in phase III trial with Fibrinogen concentrate

EQS-News: Biotest AG / Key word(s): Study results Biotest successfully meets primary endpoint in phase III trial with Fibrinogen concentrate 14.02.2024 / 08:30 CET/CEST The issuer is solely responsible for the content of this announcement.

PRESS RELEASE

 

 

Biotest successfully meets primary endpoint in phase III trial with Fibrinogen concentrate

 

• Positive results confirm excellent safety profile
• Top-line data demonstrate that Fibrinogen concentrate treatment is as effective as standard of care, either cryoprecipitate or fresh frozen plasma, in reducing intraoperative blood loss
• AdFIrst trial will be the basis for approval of Biotest’s Fibrinogen concentrate in patients with acquired fibrinogen deficiency in Europe and the United States
• Biotest’s fibrinogen concentrate aims to fulfil a high unmet medical need for additional fibrinogen concentrates to treat acquired fibrinogen deficiency, with a global market potential of USD 800 million

 

Dreieich, 14 February 2024. 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.