Grifols has completed clinical follow-up in its Phase 3 SPARTA outcomes study of Prolastin-C in patients with emphysema caused by alpha-1 antitrypsin deficiency, with topline results expected by the end of 2026.
The final participant completed their last study visit last week, an event known as last patient, last visit. The milestone marks completion of follow-up for all 345 people enrolled in the global trial, which was conducted across 37 clinical sites in 16 countries.
SPARTA, or Study of Prolastin-C Randomized Therapy with Alpha-1 Augmentation, is evaluating the clinical efficacy and safety of two weekly doses of Prolastin-C, a human alpha1-proteinase inhibitor produced through a modified manufacturing process.
The Phase 3 trial compares weekly Prolastin-C doses of 60 mg/kg and 120 mg/kg with placebo over a three-year treatment period. The study is the largest randomized, double-blind and placebo-controlled trial of augmentation therapy conducted to date in people with alpha-1 antitrypsin deficiency-associated emphysema, according to Grifols.
The primary efficacy endpoint is whole-lung computed tomography densitometry, a measure intended to assess changes in lung density and the progression of emphysema. The study also evaluates the therapy’s safety profile.
Alpha-1 antitrypsin deficiency, also known as alpha-1, is a genetic condition that can cause emphysema and other serious lung disease. The disorder results from insufficient levels of alpha-1 antitrypsin, a protein that helps protect lung tissue from damage.
Prolastin-C is an augmentation therapy intended to increase alpha-1 antitrypsin levels in affected patients. The SPARTA trial is designed to determine whether the two dose regimens can demonstrate clinical benefit in slowing lung-tissue loss compared with placebo.
Grifols said completion of the clinical phase allows the company to begin finalizing the dataset for analysis. The company expects to release topline findings before the end of the year.
The results will provide data on the potential impact of higher-dose and standard-dose Prolastin-C regimens in a large, long-term study population. Grifols did not provide a specific date for the data release or indicate whether it expects to make regulatory submissions based on the SPARTA findings.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!