Grifols Meets Enrollment Target in Phase 3 Study of Two Dose Regimens of Prolastin-C in Patients with Emphysema Due to Alpha-1-Antitrypsin Deficiency

• Target of 339 patients enrolled has been met in the SPARTA clinical trial, designed to evaluate efficacy and safety of two separate weekly doses of Grifols’ Prolastin-C (Alpha1-Proteinase Inhibitor [Human]) to slow emphysema progression in patients with alpha-1-antitrypsin (AAT) deficiency (known as alpha-1)
• Alpha-1 is the most common genetic risk factor for chronic obstructive pulmonary disease (COPD), a group of respiratory diseases that includes emphysema. COPD is the third leading cause of death worldwide¹
  
• Grifols’ advances in the science of alpha-1 underscore its robust innovation pipeline and commitment to testing and treatment for the alpha-1 community
  

BARCELONA, Spain, July 13, 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 met its enrollment target of 339 patients in SPARTA (Study of ProlAstin-c Randomized Therapy with Alpha-1 augmentation; NCT01983241), its phase 3 clinical trial designed to determine if alpha-1- antitrypsin (AAT) deficiency (alpha-1) patients with emphysema have a slower progression of lung tissue loss when treated weekly with two separate dose regimens of Grifols Prolastin-C.

Alpha-1 is an underdiagnosed² genetic disorder that can result in chronic obstructive pulmonary disease (COPD), a group of respiratory diseases that includes emphysema, which can occur when a patient has low levels of alpha-1 antitrypsin (AAT), a protective protein that safeguards the lungs. The currently approved dosage is 60 mg/kg in weekly infusions.

SPARTA, the largest randomized, double-blind, placebo-controlled study on AAT augmentation therapy to-date, is designed to evaluate the potential of Prolastin-C to significantly reduce emphysema progression in alpha-1 patients by raising AAT protein levels through weekly administration of two active dose levels versus placebo.

The clinical trial is taking place across 16 countries and more than 50 sites. It will evaluate the efficacy and safety of two separate dose regimens of Prolastin-C (60 and 120 mg/kg/week) versus placebo for 156 weeks (i.e., three years), measuring the rate of pulmonary-tissue loss through whole lung computed tomography (CT) densitometry as the primary measure of clinical efficacy.

“While alpha-1 patients currently benefit from recommended AAT augmentation therapy, we hope to show clinical evidence of benefit with the current approved dose and a greater impact by doubling the single dose to 120 mg/kg weekly,” said Sandra Camprubi, Grifols Senior Director Clinical Operations. “We look forward to providing topline data from this study in 2026 and evaluating the next regulatory steps to provide emphysema patients impactful treatment options for alpha-1.”