Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Liquid Alpha₁-PI · 1 trial · 1 indication
The primary PK objective of this study was to demonstrate the bioequivalence of Liquid Alpha₁-PI 60 mg/kg to Prolastin-C 60 mg/kg, as measured by AUC from 0 to 7 days (AUC0-7days) using an antigenic content assay of alpha₁-PI, at approximate steady state in subjects with AATD.
| Arm | Type | Description |
|---|---|---|
| Treatment Sequence 1 | OTHER | Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C |
| Treatment Sequence 2 | OTHER | Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI |
| Name | Type | Description |
|---|---|---|
| Liquid Alpha₁-PI | BIOLOGICAL | Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions |
| Prolastin-C | BIOLOGICAL | Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions |
Inclusion Criteria: * Be between 18 and 70 years of age, inclusive * Had a diagnosis of congenital AATD * Had a documented total alpha₁-PI level \< 11 µM. If the total alpha₁-PI level had yet to be documented, a blood draw for total alpha₁-PI level was obtained at the Screening Visit * Had a post-b...
Liquid Alpha₁-PI is an investigational therapy being studied for the treatment of Alpha₁-Antitrypsin Deficiency, a rare genetic condition. It is a liquid formulation of alpha₁-proteinase inhibitor (human) intended to address the deficiency of this protective protein in affected individuals.
Liquid Alpha₁-PI is being developed by Grifols, S.A., a biopharmaceutical company. Grifols is listed on the stock exchange under the ticker symbol GRFS.
Liquid Alpha₁-PI is currently in Phase 2 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being evaluated in clinical trials for safety and efficacy.
Liquid Alpha₁-PI has one completed clinical trial, registered as NCT02282527. This Phase 2 study assessed the safety and pharmacokinetics of Liquid Alpha₁-Proteinase Inhibitor (Human) in treating Alpha₁-Antitrypsin Deficiency. The trial enrolled 32 participants in the United States.
Liquid Alpha₁-PI is a monoclonal antibody designed to supplement or replace the deficient alpha₁-proteinase inhibitor in patients with Alpha₁-Antitrypsin Deficiency. By providing this protein, it aims to protect lung tissue from damage caused by uncontrolled protease activity.