Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Alpha1-proteinase inhibitor, Alpha1-Proteinase Inhibitor (Human), alpha-1 antitrypsin (AAT), BAY x 5747, BAY 10-5233, TAL-05-00007, NDC 13533-601-30, NDC 13533-601-35
Prolastin · 4 trials · 3 indications
An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product. The adverse event does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the medicinal product.
| Arm | Type | Description |
|---|---|---|
| Alpha-1 Proteinase Inhibitor (Human), modified process | EXPERIMENTAL | Study the safety and tolerability of weekly infusions of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP, 60 mg/kg) over 20 weeks of therapy in adult Alpha-1 antitrypsin deficient subjects. |
| Prolastin 120 mg/kg + Standard Medical Treatment | EXPERIMENTAL | Subjects will receive Prolastin, two intravenous infusion (IV) doses of 120 milligram per kilogram (mg/kg), based upon the subject's body weight, on Day 1 and Day 8. Subjects will also receive all standard of care interventions while hospitalized, from Day 1 to Day 29. |
| Standard Medical Treatment | ACTIVE_COMPARATOR | Subjects will receive all standard of care interventions while hospitalized, from Day 1 to Day 29. |
| Group 1 | EXPERIMENTAL | Prolastin |
| Group 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| alpha-1 proteinase inhibitor (human) | DRUG | 60 mg/kg weekly for 20 weeks |
| Prolastin | BIOLOGICAL | Intravenous infusion 120 mg/kg |
| Standard Medical Treatment | DRUG | Standard medical treatment per local policies or guidelines |
| Alpha1-Proteinase Inhibitor (Human) | DRUG | Weekly infusion of 60 mg/kg body weight for 2 years |
| Albumin (Human) 20%, United States Pharmacopeia (USP) | DRUG | Weekly infusion for 2 years. Albumin (Human) 20% will be diluted with 5% glucose to a final concentration of 2.0%. |
Inclusion Criteria: * Documented diagnosis of congenital Alpha1-antitrypsin deficiency * Documented forced expiratory volume in 1 second (FEV1 ) between 20% - 80% of predicted value within last 6 months. * Signed written informed consent prior to initiation of any study related procedures. Exclusi...
Top 9 of 11 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| Moderna, Inc. | MRNA | 2 | PHASE2 | mRNA-1283, mRNA-1273 |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
| Gilead Sciences, Inc. | GILD | 1 | PHASE2 | Remdesivir |
Prolastin is an investigational monoclonal antibody being studied for the treatment of hospitalized patients with COVID-19. It is being developed by Grifols, S.A. and has completed a Phase 2 clinical trial evaluating its safety and efficacy in this patient population.
Prolastin is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being investigated for its potential role in treating COVID-19, though the exact mechanism of action is not publicly detailed.
Prolastin is developed by Grifols, S.A., a biopharmaceutical company. Grifols is conducting clinical research on Prolastin for the treatment of COVID-19 in hospitalized patients.
Prolastin is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational, meaning it has not been approved for any use and is still undergoing clinical evaluation.
Prolastin has one completed Phase 2 clinical trial, identified as NCT04495101, which evaluated the safety and efficacy of Prolastin in hospitalized subjects with COVID-19. The trial enrolled 100 participants in Spain and was active-controlled.
Prolastin is a distinct investigational monoclonal antibody developed by Grifols. It is not known to be the same as any other approved or investigational COVID-19 therapy, and no alternative names have been associated with it.