Grifols plans to release Phase III results of its long-term albumin treatment designed to increase survival time in patients with decompensated cirrhosis and ascites in 2024, says chief scientific innovations officer Jörg Schüttrumpf.
In an exclusive interview with Pharmaceutical Technology, Schüttrumpf outlined the plasma derived-medicines company’s 2024 goals for its late-stage candidates as several trials come to a head. The aforementioned Preciosa trial (NCT03451292) studying human albumin is focused on patients awaiting a suitable transplant.
Grifols also plans to release data from its Phase III ESsCAPE study (NCT05722938), investigating trimodulin, triple action immunoglobulin with IgM, IgA and IgG, at some point this year.
In February, the company reported positive efficacy results from a trial investigating Grifols’ fibrinogen concentrate (FC), BT524, for the treatment of acquired fibrinogen deficiency (AFD). The company now plans to complete European Medicines Agency (EMA) and US Food and Drug Administration (FDA) regulatory submissions, in pursuit of approval.
Additionally, the Spain-headquartered company is exploring partnerships similar to the one it has with Ethicon, says Schüttrumpf. Grifols began its collaboration with Ethicon, a subsidiary of Johnson & Johnson, in 2017, wherein Grifols agreed to exclusively manufacture and supply plasma-derived products for use in the biosurgery field for 10 years.
In 2021, Grifols announced the acquisition of Tiancheng (Germany) Pharmaceutical Holdings, which owned 89.88% of another plasma products specialist Biotest. Grifols is developing trimodulin and BT524 with Biotest. Before the acquisition, Grifols had already explored fibrinogen concentrate for the development of Vistaseal (fibrinogen (human) + thrombin (human), commercialised as Veraseal in Europe.
Schüttrumpf highlights Grifols’ ability to complete in-house manufacturing for plasma-derived therapeutics like BT524. He said that this gave the company a major advantage in its operations, also allowing it to offer its manufacturing services to other pharmaceutical companies. “We are working with different partners. In the immunology, and pulmonary disease space, to support their growth,” says Schüttrumpf.
Grifols has plans to release its 2023 annual financial report on 29 February.
