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.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData

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.