Grifols enrolled the first patient in its Phase 3 SWIFT-SC clinical trial to evaluate its subcutaneous Alpha-1-Proteinase Inhibitor for the treatment of alpha-1-antitrypsin (AAT) deficiency.
RT’s Three Key Takeaways:
- Subcutaneous Administration: The Phase 3 SWIFT-SC trial is evaluating a 15% concentration of Alpha-1-Proteinase Inhibitor that would allow patients to self-administer treatment outside of a clinical setting.
- Clinical Comparison: Researchers are comparing the pharmacokinetics, safety, and tolerability of weekly subcutaneous doses against standard intravenous therapy in adults with alpha-1-antitrypsin deficiency.
- Expanded Research Program: This study joins the ongoing SPARTA trial, which is using computed tomography densitometry to measure the impact of augmentation therapy on lung tissue.
Grifols has enrolled the first patient in its Phase 3 SWIFT-SC clinical trial to evaluate a subcutaneous (SC) formulation of Alpha-1-Proteinase Inhibitor (Alpha-1-PI) for the treatment of alpha1-antitrypsin (AAT) deficiency, according to the company.
The study, known as SWIFT-SC, is an open-label, multicenter, randomized trial designed to determine if the subcutaneous formulation shows non-inferior pharmacokinetics compared to standard intravenous therapy. The trial will evaluate two different weekly doses of the 15% subcutaneous formulation against standard 60 mg/kg/week and 120 mg/kg/week intravenous doses in adult participants.
The investigational therapy uses a concentration approximately three times higher than the standard intravenous formulation, which enables delivery via subcutaneous administration. This method may provide benefits for patients by allowing for self-administration and reducing the need for visits to infusion centers or home healthcare providers, the company stated.
“Advancing treatment approaches is an important step forward for patients living with alpha-1-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 Alpha-1-PI therapy in a way that best aligns with individual patient preferences.”
The SWIFT-SC trial builds on a completed Phase 1/2 study and complements the company’s broader research program for AAT deficiency. This includes the ongoing SPARTA study, which is the largest prospective study to date designed to provide computed tomography (CT) densitometry efficacy data on the impact of plasma-derived augmentation therapy. Results from the SPARTA study are expected by the end of 2026.
