Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CardiolRx · 3 trials · 2 indications
time to 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 currently in clinical development and has not been approved by the FDA. The drug has received orphan drug designation for one of these indications.
CardiolRx targets the NLRP3 inflammasome, a protein complex involved in inflammatory responses. By inhibiting NLRP3, the drug aims to reduce inflammation in cardiovascular conditions such as acute myocarditis and recurrent pericarditis. This mechanism is being studied in clinical trials to assess its impact on these diseases.
CardiolRx is being developed by Cardiol Therapeutics Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol CRDL. Cardiol Therapeutics is conducting clinical trials to evaluate the safety and efficacy of CardiolRx for the treatment of cardiovascular inflammatory conditions.
CardiolRx is in Phase 2 clinical development for acute myocarditis and recurrent pericarditis. While one Phase 2 trial for recurrent pericarditis has been completed, a Phase 3 trial is currently recruiting patients. The drug is investigational and has not received FDA approval for any indication.
CardiolRx is being studied in several clinical trials. NCT06708299 is a Phase 3 trial in recurrent pericarditis, currently recruiting. NCT05494788 is a completed Phase 2 pilot study in recurrent pericarditis. NCT05180240 is a completed Phase 2 trial in acute myocarditis. These trials are designed to evaluate the drug's effects on these conditions.
No, CardiolRx is the drug being studied, while MAVERIC refers to the clinical trial programs evaluating it. The MAVERIC Phase-3 trial (NCT06708299) is investigating CardiolRx in recurrent pericarditis, and the MAvERIC-Pilot study (NCT05494788) was an earlier Phase 2 trial. These are trial names, not alternative drug names.