Positive Phase 3 Fibrinogen Trial Results Announced by Grifols

Grifols, a major global producer of plasma-derived medical products, has reported that Biotest's phase 3 clinical trial for a fibrinogen concentrate, BT524, showed promising results. The trial, known as AdFIrst, aimed at treating acquired fibrinogen deficiency (AFD), a condition that arises when there is not enough fibrinogen to stop bleeding during surgery. The study indicated that BT524 is as effective as the standard treatment in reducing blood loss and maintains a high safety standard.

Jörg Schüttrumpf, Grifols' Chief Scientific Innovation Officer, highlighted the importance of this development for patients experiencing significant blood loss during major surgeries. The standard treatments for AFD, which include cryoprecipitate and fresh frozen plasma, contain additional proteins and require thawing, making them less efficient in emergency situations. In contrast, BT524 offers a targeted approach, delivering only the necessary components to control bleeding rapidly.

The regulatory approval for BT524 is expected to commence in the fourth quarter of 2024, initially in Europe and the United States. This could mark the first fibrinogen concentrate to be approved for AFD in the U.S., with the global market for AFD estimated at around USD 800 million.

Fibrinogen, a liver-produced plasma protein, is crucial for stopping blood loss and aiding in wound healing. Grifols has previously introduced a fibrinogen-based fibrin sealant five years ago to manage surgical bleeding. The positive outcome of the Biotest fibrinogen concentrate trial is a significant step in Grifols' diversified innovation strategy, which includes both internal and external investments and spans across plasma and non-plasma products.

Victor Grifols Deu, Grifols' Chief Operating Officer, emphasized the milestone's importance in strengthening the company's innovation strategy. The detailed results of the AdFIrst trial are set to be presented later in the year.

Biotest, a part of the Grifols Group, has bolstered the company's plasma access and expanded its pipeline and sales presence. It has also brought new scientific and industrial capabilities that have contributed to Grifols' revenue growth and margin expansion through innovative plasma proteins.

The progress of BT524 is accompanied by other Biotest innovations that are contributing to Grifols' profitable growth. In 2022, Biotest launched Yimmugo®, a new immunoglobulin, in the European market, with U.S. authorization pending. Additionally, Biotest's trimodulin, a polyvalent immunoglobulin, is undergoing phase 3 clinical trials for its efficacy and safety in patients with pneumonia.

The AdFIrst trial was a prospective, active-controlled, multicenter phase 3 study that investigated the efficacy and safety of BT524 in patients with AFD. The trial compared additional blood loss between BT524 and standard treatments in patients undergoing major spinal or abdominal surgery. The trial showed BT524 to be non-inferior to the standard of care, with a significant reduction in blood loss in the BT524 group.

Fibrinogen deficiency impairs the blood's clotting ability, leading to a higher risk of bleeding and delayed haemostasis. The fibrinogen concentrate offers a tailored, patient-specific, and highly effective therapy, unlike alternatives that contain variable amounts of fibrinogen and require thawing.

Grifols, founded in Barcelona in 1909, is a global healthcare company dedicated to improving health and well-being worldwide. It is a leader in plasma-derived medicines and transfusion medicine, offering innovative healthcare services and solutions in over 110 countries. Grifols focuses on treating a wide range of conditions, from immunology to infectious diseases, and continues to grow its network of donation centers, which is the largest in the world.

With over 24,000 employees across more than 30 countries and regions, Grifols is committed to a sustainable business model that emphasizes innovation, quality, safety, and ethical leadership. The company's economic impact in 2022 was significant, contributing to job creation and economic growth. Grifols' shares are listed on the Spanish Stock Exchange and NASDAQ through ADRs.