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

About this update from Grifols, S.a. Class A

June 29, 2026 Grifols doses first participant in Phase 3 study evaluating novel subcutaneous therapy for alpha1-antitrypsin deficiency Download PDF First-of-its-kind Phase 3 study to evaluate weekly subcutaneous Alpha1-Proteinase Inhibitor, a novel approach, compared to standard intravenous therapy SWIFT-SC is an open-label, multicenter, randomized trial Positive outcome could expand treatment flexibility for patientsBarcelona, 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 alpha1-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 benefi...

View stock analysis, news, and events for Grifols, S.a. Class A