Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Humman Alpha-1 Antitrypsin, Alpha-1 Proteinase Inhibitor, API, AAT
Alpha-1 Antitrypsin · 2 trials · 2 indications
Beta cell function (measured by C peptide)
Safety and Tolerability: assessed by vital signs(systolic/diastolic blood pressure and heart rate), physical examination, routine safety lab tests, AEs and SAEs.
| Arm | Type | Description |
|---|---|---|
| Alpha1 Antitrypsin (Glassia) | EXPERIMENTAL | 60 mg/kg body weight |
| Alpha-1 Antitrypsin (Glassia) | EXPERIMENTAL | 120 mg/kg body weight |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Alpha-1 Antitrypsin 40mg (AAT, Glassia®) | EXPERIMENTAL | Subjects in this arm will receive a dose of 40 mg/kg throughout the study. |
| Alpha-1 Antitrypsin 60mg (AAT, Glassia®) | EXPERIMENTAL | Subjects in this arm will receive a dose of 60 mg/kg throughout the study. |
| Alpha-1 Antitrypsin 80mg (AAT, Glassia®) | EXPERIMENTAL | Subjects in this arm will receive a dose of 80 mg/kg throughout the study. |
| Name | Type | Description |
|---|---|---|
| Alpha-1 Antitrypsin | BIOLOGICAL | - |
| Placebo | OTHER | Placebo |
| Alpha-1 Antitrypsin 40mg (AAT, Glassia®) | DRUG | Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks. |
| Alpha-1 Antitrypsin 60mg (AAT, Glassia®) | DRUG | Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks. |
| Alpha-1 Antitrypsin 80mg (AAT, Glassia®) | DRUG | Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks. |
Main Inclusion Criteria: * Subject (or parent/guardian) willing and able to sign an informed consent * Age 8-25 (inclusive) years * Recently diagnosed with T1DM * Basal C-peptide ≥ 0.2 pmol/mL * Positive for at least one diabetes-related autoantibody * Ability and consent to comply with completion ...
Alpha-1 Antitrypsin is being studied for the treatment of New Onset Type-1 Diabetes and Type 1 Diabetes Mellitus. It is an investigational therapy, not an approved treatment, and is being developed by Kamada Ltd. as a potential disease-modifying approach in metabolic disease.
Alpha-1 Antitrypsin is developed by Kamada Ltd., which trades under the ticker KMDA. The company is advancing the asset in clinical development for Type 1 Diabetes indications.
Alpha-1 Antitrypsin is in Phase 2 clinical development. A Phase 2 study has been completed, and a Phase 1 study has also been completed. The drug remains investigational and has not been approved by the FDA for any indication.
Alpha-1 Antitrypsin has been evaluated in two completed trials: NCT02005848, a Phase 2 study of Glassia in New Onset Type-1 Diabetes with 70 participants, and NCT01304537, a Phase 1 study in Type 1 Diabetes Mellitus with 24 participants. Both were conducted in Israel.
Yes, Alpha-1 Antitrypsin is also known as Alpha-1 Antitrypsin 40mg, AAT, or Glassia. Glassia is the brand name used in the Phase 2 trial NCT02005848, which evaluated the therapy in New Onset Type-1 Diabetes.
Alpha-1 Antitrypsin is a monoclonal antibody. It is being developed for Type 1 Diabetes, where the goal is to modulate the immune response against pancreatic beta cells. The specific molecular target is not disclosed in the available program information.