Bridgewater, N.J., August 10, 2026
Grifols announced the completion of patient follow-up in SPARTA, its Phase 3 outcomes study evaluating the efficacy and safety of Prolastin-C (Alpha1-Proteinase Inhibitor [Human] modified process) in patients with emphysema associated with alpha-1 antitrypsin deficiency (AATD). The achievement of last patient, last visit (LPLV) marks completion of follow-up for all 345 participants enrolled across 37 clinical sites in 16 countries. Topline results from the study are expected by the end of 2026.
SPARTA Evaluates Prolastin-C in Alpha-1 Emphysema
The SPARTA Phase 3 study was designed to assess two weekly dose regimens of Prolastin-C — 60 mg/kg and 120 mg/kg — compared with placebo over a three-year treatment period. The randomized, double-blind, placebo-controlled trial is evaluating whether augmentation therapy can provide clinical evidence of slowing lung tissue loss in patients with emphysema caused by AATD. The study uses whole-lung computed tomography (CT) densitometry as its primary efficacy endpoint, a sensitive imaging-based approach for measuring emphysema progression and changes in lung tissue density.
Largest Randomized Alpha-1 Augmentation Study to Date
According to Grifols, SPARTA is the largest randomized, double-blind, placebo-controlled study conducted to date evaluating augmentation therapy in patients with alpha-1-related emphysema. The trial enrolled 345 patients across 16 countries, providing a substantial dataset to assess the long-term clinical impact of Prolastin-C. The three-year prospective design is intended to generate longitudinal evidence on lung tissue loss using CT densitometry, potentially providing additional clinical information on the effects of augmentation therapy in this patient population.
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Topline Results Expected by End of 2026
With the final patient completing the last study visit, Grifols has now completed the clinical follow-up phase of SPARTA. The company expects to report topline results by the end of 2026. The upcoming data will be important in determining whether the two Prolastin-C dosing regimens demonstrate evidence of slowing emphysema progression compared with placebo. Until the results are released, the clinical efficacy of the regimens in SPARTA remains unconfirmed
Grifols Advances Additional Alpha-1 Clinical Development
The SPARTA milestone is part of Grifols’ broader strategy to advance treatment options for alpha-1 antitrypsin deficiency, a genetic condition that can cause COPD and emphysema because of insufficient levels of the protective alpha-1 antitrypsin protein. Grifols has also initiated SWIFT-SC, a Phase 3 study evaluating a weekly subcutaneous alpha1-proteinase inhibitor for AATD. Together, the programs are intended to expand clinical evidence and potentially improve treatment options and administration approaches for people living with alpha-1.
Source: Grifols press release
