Grifols doses first participant in Phase 3 study evaluating novel subcutaneous therapy for alpha1-antitrypsin deficiency

Barcelona, Spain, June 29, 2026 – Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global healthcare company and leading producer of plasma-derived medicines, today announced the enrollment of the first patient in its Phase 3 SWIFT-SC clinical trial, a global study designed to evaluate a novel subcutaneous (SC) formulation of Alpha₁-Proteinase Inhibitor (Alpha₁-PI) for the treatment of alpha_1-antitrypsin (AAT) deficiency.

The SWIFT-SC study (NCT07555483) “An Open-Label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Weekly Doses of Alpha₁-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients With Alpha₁-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg/kg/Week and 120 mg/kg/Week Doses of Intravenous Alpha₁-Proteinase Inhibitor (5%)” will compare two different weekly doses of subcutaneous Alpha-15% with corresponding standard intravenous Alpha₁-PI doses.

The trial’s short name, SWIFT-SC, stands for Subcutaneous; Weekly dosing; Alpha₁ proteinase Inhibitor Formulation-focused; clinical Trial – subcutaneous (SC), representing the aim of the study. The purpose of SWIFT-SC is to determine whether the subcutaneous formulation demonstrates non-inferior pharmacokinetics compared to intravenous therapy, while also evaluating safety and tolerability. Adult participants with AAT deficiency will be randomly assigned to two treatment groups in this open-label study.

Advancing toward more flexible treatment options

SWIFT-SC is the first Phase 3 clinical trial to evaluate subcutaneous augmentation therapy in patients with AAT deficiency. This trial builds on the successful completion of the Phase 1/2 study, NCT04722887, sponsored by Grifols. The investigational therapy uses a 15% concentration, approximately three times higher than the standard intravenous formulation, enabling delivery via subcutaneous administration.

Subcutaneous administration of medicines may provide meaningful benefits for patients by enabling self-administration outside of clinical settings, reducing reliance on infusion centers or home healthcare visits, and providing greater flexibility in when and where treatment is administered.

“Advancing treatment approaches is an important step forward for patients living with alpha₁-antitrypsin deficiency,” said Eduardo Herrero, Grifols’ EVP Biopharma Industrial and Scientific Innovation. “With SWIFT-SC, we are exploring the potential to expand treatment options to deliver Alpha₁-PI therapy in a way that best aligns with individual patient preferences.”

Building on ongoing Alpha-1 research

SWIFT-SC complements Grifols’ broader clinical program in AAT deficiency, including the ongoing SPARTA study (NCT01983241), which is the largest prospective, randomized, double-blind, placebo-controlled study to date designed to provide computed tomography (CT) densitometry efficacy data on the impact of plasma-derived augmentation therapy for AAT deficiency. SPARTA is expected to complete in the second half of this year, with top-line results anticipated by year-end. Together, these studies reflect Grifols’ commitment to advancing innovative therapeutic options and improving long-term outcomes for patients with AAT deficiency.

About Alpha-1 and COPD

Alpha-1-antitrypsin deficiency, also known as alpha-1, is a rarely diagnosed genetic disease that can result in chronic obstructive pulmonary disease (COPD), a group of respiratory diseases that includes emphysema, a lung condition that causes shortness of breath. Patients who have alpha-1 have a genetic deficiency of alpha-1 antitrypsin, a protective plasma protein that safeguards the lungs from inflammation caused by infection and inhaled irritants such as tobacco smoke. Alpha-1 is the major known genetic risk factor for COPD[1].