MADRID, 14 Feb. (EUROPA PRESS) –
Grifols announced this Wednesday that the “positive” preliminary results obtained by Biotest in the phase 3 AdFIrst clinical trial of its fibrinogen concentrate (CF), BT524, mark “a milestone” in the advancement of this “potential” treatment for acquired fibrinogen deficiency (ADF), a growing market not yet covered.
CF from Biotest, a Grifols group company, has met the primary endpoint of the trial, “indicating that it is as effective as standard treatment in reducing intraoperative blood loss in patients with DAF, while maintaining excellent safety profile”, as reported this Wednesday by the blood products company in a press release.
He also highlighted that the results of this “successful” clinical trial represent “an important advance towards a potential treatment that could contribute to the care of patients who suffer serious blood loss during a major surgical intervention.”
Grifols has estimated that it will begin the regulatory authorization phase of BT524 in the fourth quarter of 2024, starting with Europe and the United States.
Specifically, this CF could be the first to be approved for a DAF indication in the United States, in a global market with an estimated potential of 800 million dollars (747.43 million euros).
Grifols’ experience with this protein in the field of surgical bleeding includes the fibrinogen-based biological fibrin sealant that the company launched five years ago.
“The positive results of Biotest’s fibrinogen are an important milestone and reinforce an innovation strategy at Grifols that is diversified into plasma and non-plasma, balanced between internal and external investments, and that includes both short- and long-term development cycles,” according to detailed the director of operations of the blood products company, Víctor Grifols Deu.
After highlighting that the detailed results of the trial will be presented this year, Grifols shares rose 1.15% on the stock market around 9:20 a.m., up to 10.54 euros per share.
