Prolastin-C (Alpha-1 MP) - (SPARTA)

Aug. 10, 2026: Grifols (MCE:GRF, MCE:GRF.P; NASDAQ: GRFS) said its Phase 3 SPARTA trial (NCT01983241) reached last-patient-last-visit, completing follow-up for all 345 patients with emphysema due to alpha-1 antitrypsin deficiency (AATD) enrolled at 37 sites in 16 countries. Topline results are expected by the end of 2026.

SPARTA is a randomized, double-blind, placebo-controlled outcomes study testing weekly Prolastin-C at 60 mg/kg and 120 mg/kg versus placebo over three years. The primary endpoint is whole-lung CT densitometry, which the company says is used to measure emphysema progression and lung tissue loss. Grifols describes SPARTA as the largest augmentation-therapy trial conducted to date in alpha-1 patients with emphysema and the first three-year prospective, double-blind, placebo-controlled CT densitometry study in this setting.

The release also notes Grifols recently started SWIFT-SC (NCT07555483), described as the first Phase 3 trial of a weekly subcutaneous alpha1-proteinase inhibitor for treatment of AATD.