Grifols Reveals Encouraging Phase 3 Fibrinogen Clinical Trial Findings

In the AdFirst trial, Biotest’s fibrinogen concentrate (FC), BT524, successfully met the primary endpoint, demonstrating its efficacy in treating acquired fibrinogen deficiency (AFD) on par with standard care, while maintaining an outstanding safety record. Regulatory approval processes in both Europe and the United States are slated to commence in the fourth quarter of 2024. If approved, this would mark the first FC to receive approval for AFD indication in the U.S., within a global AFD market estimated to reach USD 800 million. This achievement underscores Grifols’ robust innovation strategy, which strikes a balance between internal and external investments, aiming to develop a comprehensive and diversified portfolio

Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), a leading manufacturer of plasma-derived medications globally, has unveiled significant progress with Biotest’s phase 3 clinical trial, AdFIrst, evaluating its fibrinogen concentrate (FC), BT524, as a potential treatment for acquired fibrinogen deficiency (AFD), a segment of the market experiencing unmet needs.

The FC, developed by Biotest under the Grifols Group, has successfully met its primary endpoint, demonstrating efficacy comparable to standard care in reducing intraoperative blood loss among AFD patients, all while maintaining an exceptional safety profile.

Jörg Schüttrumpf, Grifols’ Chief Scientific Innovation Officer, hailed the success of the clinical trial as a pivotal step towards a potential therapy for patients encountering severe blood loss during major surgeries.

AFD, typically occurring during surgical procedures due to insufficient fibrinogen levels to stem bleeding, is conventionally managed with cryoprecipitate or fresh frozen plasma, both containing fibrinogen. However, their inclusion of unnecessary proteins and the requirement for large volumes pose challenges. Additionally, the time-consuming thawing process can be critical when lives are at stake. FC, serving as a precision medicine for AFD, provides patients on the operating table with only the essential components needed to halt hemorrhaging promptly.

BT524 is poised to undergo regulatory authorization processes in Q4 2024, commencing in both Europe and the United States. If approved, it would mark a significant breakthrough as the first FC authorized for AFD treatment in the U.S., within an estimated global market potential of USD 800 million.

Fibrinogen, a vital plasma protein produced in the liver, plays a crucial role in halting blood loss and aiding wound healing. Grifols’ expertise in managing surgical bleeding includes its fibrinogen-based fibrin sealant introduced five years ago.

Victor Grifols Deu, Grifols’ Chief Operating Officer, emphasized the importance of Biotest’s positive results, affirming Grifols’ innovation strategy’s strength, diversified across plasma and non-plasma domains, and balanced between internal and external investments, encompassing both short- and long-term development cycles.

Detailed trial results are anticipated to be disclosed later this year.

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