Grifols Completes Enrollment in Phase 3 Study of Long-term Albutein (albumin-human injection) Therapy for Patients with Decompensated Cirrhosis

• PRECIOSA clinical trial is designed to evaluate efficacy and safety of Grifols Albutein plus standard medical treatment to increase survival time in patients with decompensated cirrhosis awaiting transplant
  
• Albumin’s antioxidant and anti-inflammatory properties have the potential to mitigate the complications associated with decompensated cirrhosis
  
• Grifols continues innovating across its plasma-protein franchise and is committed to applying its ever-growing expertise in a range of therapeutic areas to help treat pressing societal healthcare challenges
  
  

BARCELONA, Spain, July 18, 2023 (GLOBE NEWSWIRE) -- Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), one of the world’s leading producers of plasma-derived medicines, today announced it has completed enrollment in PRECIOSA (NCT03451292), its phase 3 clinical trial designed to determine the potential of long-term albumin treatment with Grifols Albutein to increase survival time in patients with decompensated cirrhosis and ascites until a suitable transplant is available.

Cirrhosis, a condition in which the liver is permanently scarred and can lead to liver failure, is the leading cause of liver-related deaths globally,¹ with more than 1.32 million deaths reported in 2017.² In the U.S. alone, researchers estimate that about 1 in 400 adults have cirrhosis,³ including those who have progressed into decompensated cirrhosis once complications such as ascites appear. Ascites is a buildup of fluid in the abdomen and signals that a patient’s risk for poor outcomes, including death, have significantly increased.

Albumin, the most abundant protein in plasma, has antioxidant and anti-inflammatory properties with the potential to mitigate the complications associated with decompensated cirrhosis and its progression into the next stage of the disease, acute-on-chronic liver failure (ACLF). Treatment with albumin has the potential to reduce the high one-year mortality rates observed in decompensated cirrhosis.

Over 400 patients with decompensated cirrhosis with ascites are participating in this multi-center, randomized (1:1), controlled, parallel-group, open-label study in 69 sites across North America and Europe. It will evaluate the efficacy and safety of long-term Albutein administration (dosed every 10 ± 2 days for up to 12 months) plus standard medical treatment.

“There is great potential for albumin to improve the survival prospects of patients suffering from decompensated cirrhosis until they can get a liver transplant, a large unmet need given the limited availability of livers for patients,” said Sandra Camprubi, Grifols Senior Director Clinical Operations. “We look forward to providing topline data from this study in the fourth quarter of 2024 and evaluating next regulatory steps to provide patients with a much-needed treatment.”