Approval Probability
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ML Risk
Also known as ISIS-APO(a)Rx
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 developed for elevated lipoprotein(a), a cardiovascular risk factor. It was studied in a Phase 2 trial in adults with high lipoprotein(a) levels. The drug has not been approved for any indication and remains in clinical development.
ISIS-APORx is developed by Ionis Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker IONS. Ionis is the sponsor of the clinical program for this investigational asset.
ISIS-APORx is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are ongoing. The drug is investigational and has not received FDA approval.
ISIS-APORx has been evaluated in one completed Phase 2 trial, NCT02160899, titled "Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS-APO(a)Rx in Participants With High Lipoprotein(a)." The randomized, double-blind, placebo-controlled study enrolled 64 participants across Canada, Denmark, Germany, the Netherlands, and the United Kingdom.
Yes, ISIS-APORx is also known as ISIS-APO(a)Rx. Both names refer to the same investigational drug developed by Ionis Pharmaceuticals for elevated lipoprotein(a).