Grifols’ positive fibrinogen Phase III trial results published

Spanish plasma-derived medicines specialist Grifols (MCE: GRF) announced that the positive Phase III study data on its fibrinogen concentrate, BT524, has been published in eClinicalMedicine, a peer-reviewed journal published by The Lancet Discovery Science Suite.

The article highlights that the trial met its primary endpoint, demonstrating that treatment with BT524 is non-inferior to standard of care (SOC) with cryoprecipitate or fresh frozen plasma (FFP) in reducing clinically relevant intraoperative bleeding in patients with acquired fibrinogen deficiency (AFD) undergoing planned major spinal or abdominal surgery.

Specifically, the Barcelona-based company noted, the adjusted mean of intraoperative blood loss was 1381 mL (95% confidence interval [CI] 1187–1574) in the BT524 group and 1660 mL (95% CI 1461–1860) in the FFP/cryoprecipitate group, resulting in a difference of blood loss of 279 mL between the study groups. BT524 demonstrated a positive safety profile and a statistically significant lower incidence of thromboembolic events (TEEs).