Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CardiolRx · 3 trials · 2 indications
proportions of patients free from a new episode of recurrent pericarditis\* from the timepoint of stopping the IL-1 blocker to Week 24
Change in pain score from baseline using 11-point NRS after 8 weeks of treatment. Nominal Rating Scale from 0 to 10, where 0 represents no pain and 10 maximum pain.
Change of ECV from baseline at 12 weeks, measured by cardiac Cardiac MRI. ECV is measuring the degree of edema and fibrosis. The unit of measure was percentage. It was the percentage of myocardial tissue that is extracellular space (i.e. fraction of the myocardium occupied by extracellular matrix and interstitial fluid).
The outcome was the change in GLS from baseline at 12 weeks, measured by cardiac Cardiac MRI. GLS is a predictor of cardiac function. The unit of measure is percentage. It is the percent change in myocardial length relative to its original (end-diastolic) length along the long axis. Longitudinal strain during systole is usually negative, because the ventricle shortens; normal peak GLS in healthy adults is around -20% (i.e., 20% shortening relative to original length)
| Arm | Type | Description |
|---|---|---|
| CardiolRx | ACTIVE_COMPARATOR | * Initial starting dose (Day 1, evening dose to Day 3, morning dose): 5 mg/kg of body weight CardiolRx b.i.d. * Day 3, evening dose to Day 10, morning dose: 7.5 mg/kg of body weight CardiolRx b.i.d. * Day 10, evening dose to morning dose of the Week 24 Visit: 10 mg/kg of body weight CardiolRx b.i.d. |
| Placebo | PLACEBO_COMPARATOR | * Initial starting dose (Day 1, evening dose to Day 3, morning dose): 5 mg/kg of body weight matching placebo b.i.d. * Day 3, evening dose to Day 10, morning dose: 7.5 mg/kg of body weight matching placebo b.i.d. * Day 10, evening dose to morning dose of the Week 24 Visit: 10 mg/kg of body weight matching placebo b.i.d. |
| Name | Type | Description |
|---|---|---|
| CardiolRx | DRUG | The intervention will be administered orally (via syringe) with food twice daily. |
Inclusion Criteria: 1. Patients 18 years of age or older 2. A history of recurrent pericarditis with stable disease and currently being treated with an IL-1 blocker, scheduled to be discontinued. Stable disease is defined as: * treatment with an IL-1 blocker for at least 12 months, * free of...
CardiolRx is an investigational small molecule being developed for cardiovascular conditions, specifically acute myocarditis and recurrent pericarditis. It is a Phase 2 drug candidate from Cardiol Therapeutics Inc. (CRDL) that has been studied in clinical trials for these inflammatory heart conditions.
CardiolRx is a small molecule therapeutic being developed by Cardiol Therapeutics Inc. (CRDL) for cardiovascular inflammatory conditions. While the specific molecular target is not disclosed in available information, it is being investigated for its effects on myocardial recovery in acute myocarditis and for reducing recurrent pericarditis episodes.
CardiolRx is being developed by Cardiol Therapeutics Inc., a biopharmaceutical company traded on the stock exchange under the ticker CRDL. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with acute myocarditis and recurrent pericarditis.
CardiolRx is currently in Phase 2 clinical development. It has completed two Phase 2 trials: one in acute myocarditis (NCT05180240) and one in recurrent pericarditis (NCT05494788). A Phase 3 trial in recurrent pericarditis (NCT06708299) is currently recruiting participants.
CardiolRx has been studied in two completed Phase 2 trials: NCT05180240 in acute myocarditis with 109 participants and NCT05494788 in recurrent pericarditis with 27 participants. A Phase 3 trial, NCT06708299, is currently recruiting for recurrent pericarditis with a target enrollment of 110 participants.
CardiolRx is not FDA approved. It is an investigational drug currently in clinical development. It has received orphan drug designation from the FDA, which is granted to drugs intended to treat rare diseases, but this does not mean it is approved for marketing.