Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ISIS-APORx · 1 trial · 1 indication
Data are reported for evaluable participants.
An adverse event is any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product.
| Arm | Type | Description |
|---|---|---|
| Cohort A: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| Cohort A: ISIS-APO(a)Rx < 2000 mg | EXPERIMENTAL | Participants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated. |
| Cohort A: ISIS-APO(a)Rx >= 2000 mg | EXPERIMENTAL | Participants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated. |
| Cohort B: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo (normal saline) subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
| Cohort B: ISIS-APO(a)Rx < 2000 mg | EXPERIMENTAL | Participants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated. |
| Cohort B: ISIS-APO(a)Rx >= 2000 mg | EXPERIMENTAL | Participants will receive ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated. |
| Name | Type | Description |
|---|---|---|
| ISIS-APO(a)Rx | DRUG | ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated. |
| Placebo | DRUG | Normal saline as Placebo, subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. |
Inclusion Criteria: * Males or females aged 18-65 inclusive * Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal (defined as 12 months of spontaneous amenorrhea witho...
ISIS-APORx is an investigational drug being developed for elevated lipoprotein(a), a condition associated with increased cardiovascular risk. It is intended to lower elevated levels of lipoprotein(a) in patients with high levels of this lipid. The drug is currently in clinical development and has not been approved by regulatory authorities.
ISIS-APORx is designed to target apolipoprotein(a), the protein component of lipoprotein(a). By targeting this protein, the drug aims to reduce the production of lipoprotein(a) particles in the body, thereby lowering elevated lipoprotein(a) levels. This mechanism is being evaluated in clinical trials for its potential to address cardiovascular risk associated with high lipoprotein(a).
ISIS-APORx is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company focused on RNA-targeted therapies. Ionis Pharmaceuticals is publicly traded under the ticker symbol IONS on the NASDAQ stock exchange. The company is responsible for the clinical development and potential commercialization of ISIS-APORx.
ISIS-APORx is in Phase 2 of clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 2 trial has been completed, and the drug is no longer in active clinical trials. Further development status beyond Phase 2 has not been disclosed.
ISIS-APORx has been studied in one clinical trial with the identifier NCT02160899. This Phase 2 trial, titled 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS-APO(a)Rx in Participants With High Lipoprotein(a),' enrolled 64 participants with elevated lipoprotein(a). The study was completed and was conducted in Canada, Denmark, Germany, Netherlands, and the United Kingdom.
Yes, ISIS-APORx is also known as ISIS-APO(a)Rx. The clinical trial NCT02160899 uses the name ISIS-APO(a)Rx to refer to the same investigational drug. Both names refer to the same compound being developed by Ionis Pharmaceuticals for elevated lipoprotein(a).