Grifols announces positive topline phase 3 fibrinogen clinical trial results

• In the AdFIrst study, Biotest's fibrinogen concentrate (FC), BT524, met the primary endpoint, demonstrating its effectiveness in treating acquired fibrinogen deficiency (AFD) as equivalent to standard of care, while maintaining an excellent safety profile
  
  
• Regulatory approval process in Europe and United States set to begin in Q4 2024. It would be the first FC approved for an AFD indication in the U.S. in a global market for AFD with an estimated potential of USD 800 million
  
  
• This milestone is part of Grifols’ robust innovation strategy, balancing internal and external investments to build a comprehensive and diversified portfolio
  

BARCELONA, Spain, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s leading producers of plasma-derived medicines, today announced that Biotest’s positive topline results from AdFIrst, its phase 3 clinical trial of its fibrinogen concentrate (FC), BT524, advance this potential treatment for acquired fibrinogen deficiency (AFD), an underserved growth market.

The FC from Biotest, a Grifols Group company, met the primary endpoint. It is as effective as standard of care in reducing intraoperative blood loss in patients with AFD, while also maintaining an excellent safety profile.

“This successful clinical trial is a significant stride towards a potential therapy that could contribute to the care of patients who experience severe blood loss during major surgery,” said Jörg Schüttrumpf, Grifols Chief Scientific Innovation Officer.

AFD, which typically occurs during surgical procedures when there’s insufficient fibrinogen to arrest bleeding, is commonly treated with cryoprecipitate (a plasma extract) or fresh frozen plasma, both containing fibrinogen.

The drawback is that they also contain other proteins and elements that aren’t necessary, so large volumes are needed to ensure enough fibrinogen. Plus both need to be thawed in advance, time consuming when lives are at risk. FC, which is also used to treat AFD, is a precision medicine in which patients on the operating table immediately receive only what’s essential to curtail hemorrhaging.

BT524 will likely enter regulatory authorization processes in Q4 2024 starting in Europe and the United States. It would be the first FC approved for an AFD indication in the U.S. in a global market with an estimated potential of USD 800 million.

Fibrinogen, a plasma protein produced in the liver, plays a key role in stopping blood loss and in wound healing. Grifols’ experience with it to manage surgical bleeding includes the fibrinogen-based fibrin sealant the company launched five years ago.