Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ISIS CRP Rx · 2 trials · 2 indications
Burden measured as percentage of time spent in AF as derived from continuous pacemaker monitoring
Adverse events, laboratory tests, and vital signs
| Arm | Type | Description |
|---|---|---|
| Group A | EXPERIMENTAL | ISIS CRP Rx followed by Placebo |
| Group B | EXPERIMENTAL | Placebo followed by ISIS CRP Rx |
| Group C | EXPERIMENTAL | Dose 3 ISIS CRP Rx versus Placebo |
| Name | Type | Description |
|---|---|---|
| ISIS CRP Rx | DRUG | - |
| Placebo | DRUG | - |
| ISIS CRP Rx or Placebo | DRUG | - |
Inclusion Criteria: * Male of female; age over 18 years * Dual chamber permanent pacemaker implanted * Confirmed diagnosis of paroxysmal atrial fibrillation with an AF burden of 1 to 50%, as derived from pacemaker diagnostic algorithms * Able to have pacemaker antiarrhythmic algorithms turned off f...
ISIS CRP Rx is an investigational small molecule developed by Ionis Pharmaceuticals, Inc. (ticker IONS). It has been studied in Phase 2 clinical trials for two indications: paroxysmal atrial fibrillation and rheumatoid arthritis. It is not an approved therapy and remains in clinical development.
ISIS CRP Rx has been evaluated in clinical trials for paroxysmal atrial fibrillation, a heart rhythm condition, and for rheumatoid arthritis, an inflammatory joint disease. Both programs reached Phase 2. No approved use has been established for ISIS CRP Rx.
ISIS CRP Rx is developed by Ionis Pharmaceuticals, Inc., which trades under the ticker symbol IONS. Ionis sponsored the Phase 2 studies of the drug in paroxysmal atrial fibrillation and rheumatoid arthritis.
ISIS CRP Rx is in Phase 2 development. Two Phase 2 trials have been completed, one in paroxysmal atrial fibrillation and one in rheumatoid arthritis. The drug is investigational and has not been approved by the FDA for any indication.
ISIS CRP Rx has been studied in two completed Phase 2 trials. NCT01710852 tested ISIS CRP Rx in paroxysmal atrial fibrillation in the United Kingdom with 7 participants. NCT01414101 assessed safety, tolerability, and pharmacodynamics in rheumatoid arthritis in Canada and Russia with 51 participants.
ISIS CRP Rx is a small molecule designed to target C-reactive protein, or CRP. By targeting CRP, the drug aims to reduce inflammation-driven processes relevant to paroxysmal atrial fibrillation and rheumatoid arthritis. Both Phase 2 trials evaluating this approach have been completed.