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Alpha-1 15% · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Treatment Arm 1 (60 mg/kg/week of Liquid Alpha1-PI followed by 90 mg/kg/week of Alpha-1 15%) | EXPERIMENTAL | 8 weeks of IV treatment with 60 mg/kg/week Liquid Alpha1-PI followed by 8 weeks of SC treatment with 90 mg/kg/week Alpha-1 15% |
| Treatment Arm 2 (120 mg/kg/week of Liquid Alpha1-PI followed by 180 mg/kg/week of Alpha-1 15%) | EXPERIMENTAL | 8 weeks of IV treatment with 120 mg/kg/week Liquid Alpha1-PI followed by 8 weeks of SC treatment with 180 mg/kg/week Alpha-1 15% |
| Cohort 1: Treatment Period 1 (Alpha-1 15%, 72 mg/kg) | EXPERIMENTAL | Participants will receive Alpha-1 15% 72 mg/kg, single weekly subcutaneous (SC) infusion in treatment-period 1 (Single-Dose) at Week 1. |
| Cohort 1: Single-Dose Data Evaluation Period (Liquid Alpha 1-Proteinase Inhibitor 60 mg/kg) | EXPERIMENTAL | Following treatment period 1, participants in Cohort 1 will enter 21 days of washout/serial pharmacokinetic (PK) phase and then the single-dose data evaluation period. During the single-dose data evaluation phase, Liquid Alpha1- Proteinase Inhibitor (PI) 60 mg/kg, weekly intravenous (IV) Infusions will be administered from intravenous-dose Week 1 (single-dose Week 5) for up to Week 78, with the last IV dose given 1 week prior to the first repeat Alpha-1 15% SC dose. |
| Cohort 1: Treatment Period 2 (Alpha-1 15%, 72 mg/kg) | EXPERIMENTAL | Following treatment period 1 and single-dose data evaluation period, participants in Cohort 1 will enter treatment period 2 (Repeat-Dose) and will receive Alpha-1 15% 72 mg/kg, for 8 weekly SC infusions. |
| Cohort 2: Treatment Period 1 (Alpha-1 15%, 180 mg/kg) | EXPERIMENTAL | Participants will receive Alpha-1 15% 180 mg/kg, single weekly SC infusion in treatment-period 1 (Single-Dose) at Week 1. |
| Cohort 2: Single-Dose Data Evaluation Period (Liquid Alpha1-Proteinase Inhibitor 120 mg/kg) | EXPERIMENTAL | Following treatment period 1, participants in Cohort 2 will enter 21 days of washout/serial pharmacokinetic (PK) phase and then the single-dose data evaluation phase. During the single-dose data evaluation phase, Liquid Alpha1-PI 120 mg/kg, weekly IV Infusions will be administered from intravenous-dose Week 1 (single-dose Week 5) for up to Week 78, with the last IV dose given 1 week prior to the first repeat Alpha-1 15% SC dose. |
| Cohort 2: Treatment Period 2 (Alpha-1 15%, 180 mg/kg) | EXPERIMENTAL | Following treatment period 1 and single-dose data evaluation phase, participants in Cohort 2 will enter treatment period 2 (Repeat-Dose) and will receive Alpha-1 15% 180 mg/kg, for 8 weekly SC infusions. |
| Name | Type | Description |
|---|---|---|
| Alpha-1 15% | DRUG | Alpha1-Proteinase Inhibitor Subcutaneous (Human), 15% |
| Liquid Alpha1-PI | OTHER | Liquid Alpha1-Proteinase Inhibitor (Human) for Intravenous infusion |
| Liquid Alpha1-Proteinase Inhibitor (Human) | BIOLOGICAL | Intravenous infusion |
Inclusion Criteria: * Have a diagnosis of congenital AATD with an allelic combination of ZZ, SZ, Z(null), (null)(null), S(null), or "at-risk" alleles (patients with "at-risk" alleles must be individually evaluated for eligibility by the Medical Monitor). If the genotype has yet to be documented, a ...
Alpha-1 15% is an investigational therapy for Alpha-1 Antitrypsin Deficiency (AATD), a genetic condition that can lead to lung and liver disease. It is being developed as a subcutaneous formulation of alpha1-proteinase inhibitor for patients with this deficiency. The drug is currently in Phase 3 clinical development and is not yet approved.
Alpha-1 15% is being developed by Grifols, S.A., a biopharmaceutical company. Grifols is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this subcutaneous alpha1-proteinase inhibitor in patients with Alpha-1 Antitrypsin Deficiency.
Alpha-1 15% is currently in Phase 3 clinical development. A Phase 3 study is recruiting participants to compare the pharmacokinetics and safety of weekly subcutaneous Alpha-1 15% with standard intravenous alpha1-proteinase inhibitor in patients with Alpha-1 Antitrypsin Deficiency.
Alpha-1 15% is being studied in a Phase 3 trial with the identifier NCT07555483, which is recruiting 40 participants across multiple countries including the United States, Denmark, Germany, Ireland, Netherlands, Poland, Portugal, Spain, and Sweden. A Phase 1 trial, NCT04722887, has been completed.
Alpha-1 15% is an alpha1-proteinase inhibitor, a protein that helps protect lung tissue from damage caused by enzymes such as neutrophil elastase. In patients with Alpha-1 Antitrypsin Deficiency, this protein is deficient, and supplementation aims to restore protective levels to slow disease progression.