Grifols meet enrollment target in Phase 3 study of Prolastin-C

Grifols announced it has met its enrollment target of 339 patients in SPARTA, its phase 3 clinical trial designed to determine if alpha-1- antitrypsin deficiency patients with emphysema have a slower progression of lung tissue loss when treated weekly with two separate dose regimens of Grifols Prolastin-C. 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 versus placebo for 156 weeks, measuring the rate of pulmonary-tissue loss through whole lung computed tomography 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.”