Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
COR-001 · 1 trial · 1 indication
The MTD assessment was based on safety data. If more than 2 of 8 active participants in a cohort experience a Dose-Limiting Toxicities (DLT), the MTD was considered to have been exceeded. The DLT threshold was defined using a threshold of greater than or equal to (\>=) Grade 3 events, which includes severe: infusion-related reactions, cardiopulmonary infusion reactions, anaphylaxis, or hypersensitivity. DLTs are defined as follows: 1. Confirmed Grade 3 neutropenia and representing a decline of \> 25% from baseline 2. Serious adverse events (SAEs) of infection in the presence of confirmed Grade 2 or higher new onset lymphopenia or new onset neutropenia. 3. ≥ Grade 3 ALT (Alanine transaminase) or AST(Aspartate transaminase) 4. ≥ Grade 4 hematologic toxicity 5. ≥ Grade 3 non-hematologic toxicity
Change from the baseline in hsCRP values to week 4 are presented.
Change from the baseline in serum amyloid A (SAA) values to week 4 are presented.
| Arm | Type | Description |
|---|---|---|
| COR-001 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| COR-001 | DRUG | - |
| Placebo | OTHER | - |
INCLUSION CRITERIA 1. Age greater than or equal to 18 years at the time of signing of the ICF. 2. The patient agrees to comply with the contraception and reproduction restrictions of the study 3. Receiving intravenous (IV) or subcutaneous (SC) erythropoietin stimulating agents (ESA) drugs continuou...
COR-001 is an investigational small molecule being developed for the treatment of anemia. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied to assess its safety, pharmacokinetics, and pharmacodynamics in patients with anemia.
COR-001 is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical research to evaluate the drug's potential as a treatment for anemia.
COR-001 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for commercial use. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research for the treatment of anemia.
COR-001 has been studied in one completed Phase 1 clinical trial with the identifier NCT02868229. This trial assessed the safety, pharmacokinetics, and pharmacodynamics of multiple doses of COR-001 in 61 participants with anemia in the United States. The trial was randomized, double-blind, and placebo-controlled.
COR-001 is a small molecule being developed for anemia, but its specific molecular target has not been disclosed. As a small molecule, it is designed to be administered orally or by other routes, but the exact mechanism of action is not publicly detailed in the available information.