Grifols has met the target enrolment of 339 subjects in the Study of ProlAstin-c Randomized Therapy with Alpha-1 augmentation (SPARTA) Phase III trial to treat emphysema.
The placebo-controlled, double-blind, randomised study is designed to assess the safety and efficacy of 60mg/kg and 120mg/kg doses of Alpha1-Proteinase inhibitor Prolastin-C given once a week against placebo in slowing down the progression of lung tissue loss in emphysema patients.
Patients with alpha-1-antitrypsin (AAT) deficiency also called alpha-1 are enrolled on the study planned to be carried out across 16 countries and more than 50 centres.
The study will also measure the rate of pulmonary-tissue loss as the primary measure of clinical efficacy. It is determined using whole lung computed tomography (CT) densitometry.
Grifols Clinical Operations senior director Sandra Camprubi said: “While alpha-1 patients currently benefit from recommended AAT augmentation therapy, we hope to show clinical evidence of benefit with the currently approved dose and a greater impact by doubling the single dose to 120mg/kg weekly.
“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.”
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SPARTA is claimed to be the largest study on AAT augmentation therapy till now.
With the commitment to support the community of alpha-1, the company introduced AlphaID At Home Genetic Health Risk Service (AlphaID At Home). It is a direct-to-consumer programme in the US to screen for the genetic alpha-1 risk.