Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Ziltivekimab
COR-001 · 8 trials · 12 indications
Change in percent atheroma volume (PAV) as determined by greyscale intravascular ultrasound (IVUS) in matched regions of interest. Theoretical change is between -100% to +100%. Typical range around -2% to +2%. A lower (more negative) change in PAV is better.
Percentage (%).
Measured in months.
Measured as score (score on scale; range; 0-100). The KCCQ is a disease-specific health status instrument composed of 23 items that quantify the domains of physical limitation, symptoms, self-efficacy, social limitation, and health-related quality of life limitation from heart failure. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. CSS scores range from 0 to 100 and lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Percent change in hs-CRP levels from baseline (average of the hs-CRP value prior to the administration of study drug) to the end of treatment (average of Week 10 and Week 12) is presented. Baseline was defined as the average of all hs-CRP values prior to the first administration of study drug at day 1 and end of treatment was defined as the average of hs-CRP values at week 10 and week 12.
Percent change from baseline in hs-CRP levels at week 13 are presented.
Nanograms per millilitre\*days (ng/mL\*days)
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 |
|---|---|---|
| Ziltivekimab Arm | EXPERIMENTAL | Participants will receive Ziltivekimab subcutaneously once per month |
| Placebo Arm | PLACEBO_COMPARATOR | Participants will receive placebo subcutaneously once per month |
| Ziltivekimab dose level 1 + standard of care (SOC) | EXPERIMENTAL | Participants receive dose level 1 of ziltivekimab along with standard of care (SOC) subcutaneously once monthly for 12 months. |
| Placebo + SOC | PLACEBO_COMPARATOR | Participants receive a placebo along with standard of care (SOC) subcutaneously once monthly for 12 months. |
| Ziltivekimab | EXPERIMENTAL | Participants will receive an initial loading dose of ziltivekimab Dose 1 subcutaneously (s.c.) as early as possible after invasive procedure, and latest within 36 hours of hospitalisation for ST-elevation myocardial infarction (STEMI) and within 48 hours of hospitalisation for non-ST-elevation myocardial infarction (NSTEMI), followed by ziltivekimab Dose 2 s.c. once-monthly during the treatment period (estimated up to 2 years) added to standard of care. |
| Placebo ziltivekimab | EXPERIMENTAL | Participants will receive placebo matched to ziltivekimab at an initial loading dose subcutaneously (s.c.) as early as possible after invasive procedure, and latest within 36 hours of hospitalisation for STEMI and latest within 48 hours of hospitalisation for NSTEMI, followed by placebo matched to ziltivekimab s.c. once-monthly during the treatment period (estimated up to 2 years) added to standard of care. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matched to ziltivekimab administered s.c. once-monthly and added to standard of care for 12 months. |
| Ziltivekimab 15 mg | EXPERIMENTAL | Participants will receive ziltivekimab 15 mg for 12 weeks. |
| Ziltivekimab 30 mg | EXPERIMENTAL | Participants will receive ziltivekimab 30 mg for 12 weeks. |
| Placebo (ziltivekimab) | PLACEBO_COMPARATOR | Participants will receive placebo (ziltivekimab) for 12 weeks. |
| Ziltivekimab 7.5 mg | EXPERIMENTAL | - |
| COR-001 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Ziltivekimab | DRUG | Ziltivekimab is administered subcutaneously (i.e., under the skin) once per month added to standard of care. |
| Placebo | DRUG | Placebo is administered subcutaneously (i.e., under the skin) once per month added to standard of care. |
| Ziltivekimab Placebo | DRUG | Participants will receive placebo matched to ziltivekimab subcutaneously. |
| Placebo (ziltivekimab) | DRUG | Administered s.c. once every 4 weeks for 12 weeks |
| COR-001 | DRUG | - |
Key Inclusion Criteria: * Informed consent obtained before any study-related activities. * Age 18 years or above at the time of providing informed consent. * Acute myocardial infarction, with at least one coronary segment (culprit lesion) treated with PCI. * At least two major native coronary arter...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | Luspatercept |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Disc Medicine, Inc. | IRON | 2 | PHASE2 | DISC-0974 |
| Akebia Therapeutics, Inc. | AKBA | 2 | PHASE3 | Vadadustat |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | APG-5918 |
| Bayer | BAYRY | 1 | - | Molidustat |
COR-001 is an investigational monoclonal antibody being developed by Novo Nordisk for the treatment of anemia, a hematology condition marked by low red blood cell counts. It is in Phase 1 clinical development and has not been approved for any use.
COR-001 is being developed by Novo Nordisk A/S, which trades on the New York Stock Exchange under the ticker NVO. Novo Nordisk is the sponsor of the clinical program evaluating the monoclonal antibody in anemia.
COR-001 is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA or any other regulatory agency. One Phase 1 trial has been completed, and no trials are currently active.
COR-001 has been studied in one completed Phase 1 trial, NCT02868229, titled a study to assess the safety, pharmacokinetics, and pharmacodynamics of multiple doses of COR-001. The trial enrolled 61 participants with anemia in the United States and was randomized, double-blind, and placebo-controlled.
The COR-001 Phase 1 trial NCT02868229 was a randomized, double-blind, placebo-controlled study that enrolled 61 adults aged 18 years and older with anemia. It took place in the United States, evaluated multiple doses of the monoclonal antibody, and assessed safety, pharmacokinetics, and pharmacodynamics. The trial is now completed.