What is the Investigational Product in the Cardiol 100-004 Study?
CardiolRx™ is a pharmaceutically manufactured synthetic cannabidiol solution, formulated for oral administration. Cannabidiol is known to have anti-inflammatory properties.
Although the mechanisms of CardiolRx™’s anti-inflammatory effects are not fully understood, research suggests that the drug substance in CardiolRx™ attenuates multiple inflammatory signaling pathways, including inhibiting activation of the NLRP3 inflammasome.
Pericardial insult or viral infection results in aberrant expression and activation of the NLRP3 inflammasome protein components which induce the release of pro-inflammatory cytokines (e.g., IL-1α, IL-1β, IL-6, & IL-18). This pro-inflammatory cytokine release perpetuates endothelial dysfunction, impairs vasodilation, and activates leukocytes, thereby leading to pericardial damage, increased pericardial space and thickness, and a cyclic release of IL-1α.
The drug substance in CardiolRx™ has been shown to significantly decrease the pro-inflammatory cytokines IL-1β and IL-6 and inhibit pro-IL-1β and NLRP3 mRNA expression in vitro, and significantly reduce pericardial effusion and thickness in a murine model of acute pericarditis.
NLRP3 = NACHT, leucine-rich repeat, and pyrin domain-containing protein 3
Who is Eligible for the Study?
Key Inclusion Criteria:
- Male or female patients aged ≥18 years
- Diagnosis of at least 2 episodes of recurrent pericarditis
- At least 1 day with pericarditis pain score ≥4 on the 11-point NRS within the prior 7 days
- C-reactive protein level ≥1.0 mg/dL OR evidence of pericardial inflammation assessed by delayed pericardial hyperenhancement on cardiac magnetic resonance imaging
- Currently receiving non-steroidal anti-inflammatory drugs (NSAIDs), colchicine or corticosteroids for treatment of pericarditis (in any combination) in stable doses
Key Exclusion Criteria:
- Diagnosis of pericarditis secondary to the following etiologies:
- Neoplastic, purulent or radiation etiology
- Post-thoracic blunt trauma
- Prior history of sustained ventricular arrhythmias or QT interval prolongation
- Taken any cannabinoid in the past month
- Current diagnosis of cancer (except for non-melanoma skin cancer)
- Immunosuppressive therapy with any of the following treatments: rilonacept; anakinra; canakinumab; methotrexate; azathioprine; cyclosporine; intravenous immune globulin (IVIG)
Additional eligibility criteria will be assessed by the study team during screening.
What is Expected of Study Participants?
The patient will review the detailed information about the study in an informed consent form (ICF) and provide written consent prior to the administration of any study-related assessments, procedures and treatment.
Participants will have to rate their NRS pain score either on paper or via an electronic patient portal.
Participants must not take any prohibited concomitant medications during the study including:
- Digoxin and/or type 1 or 3 antiarrhythmics
- Immunosuppressive therapies including rilonacept, anakinra, canakinumab, methotrexate, azathioprine, cyclosporine, intravenous immunoglobulin
Participants are expected to attend scheduled study visits whether in clinic or virtually (by phone or video call).
Frequently Asked Questions
Yes. A Phase 1 safety and pharmacokinetic study of single and multiple ascending doses of CardiolRx™ was completed and demonstrated that CardiolRx™ was safe and generally well tolerated at all dose levels, with no serious adverse events reported. In addition to the MAvERIC-Pilot study, CardiolRx™ is also being investigated in the Phase 2 multi-national ARCHER trial to evaluate its safety and tolerability as well as its impact on myocardial recovery, in patients presenting with acute myocarditis (ClinicalTrials.gov Identifier: NCT05180240).
No. However, another form of cannabidiol oral solution (Epidiolex®) is FDA-approved and indicated for the treatment of seizures associated with certain epilepsy syndromes.
CardiolRx™ is pharmaceutically manufactured under Current Good Manufacturing Practice (cGMP), contains synthetic, high-concentration (100 mg/mL) cannabidiol, and does not contain delta-9 THC (not detected at limit of detection 5 parts per million).
The study medication and all tests and procedures required by the study are provided at no cost to study participants. The costs of other medications, treatments, and procedures used independently of the MAvERIC-Pilot study are not covered by the Sponsor.
Participants will not be paid for being in this study, but will be reimbursed for reasonable expenses (e.g., travel, parking, meals) arising from outpatient visits.
If you have patients under your care who may be eligible for this study, please consider them for referral to the participating sites listed below.
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
Contact: David Lin, MD
Referring patients | Allina Health Minneapolis Heart Institute | Allina Health
Rochester, Minnesota, United States, 55905
Contact: S. A. Luis, MD
Principal Investigator: S. A. Luis, MD
Provider relations – Medical Professionals – Mayo Clinic
Cleveland, Ohio, United States, 44195
Contact: Sonya Mihalus, BSN
Medical Professionals: Refer a Heart Patient | Cleveland Clinic