Cardiol Therapeutics Enrolls First Patient in Pivotal Phase III MAVERIC Trial in Recurrent Pericarditis
Toronto, Ontario--(Newsfile Corp. - April 16, 2025) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ('Cardiol' or the 'Company'), a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announced today that Northwestern University has enrolled the first patient in the pivotal Phase III MAVERIC trial ('MAVERIC') evaluating Cardiol's lead drug candidate CardiolRx™ for the prevention of recurrent pericarditis. This multi-center, randomized, double-blind, placebo-controlled trial is designed to definitively assess the impact of CardiolRx™ on preventing recurrent pericarditis in patients at high risk for disease relapse and to support regulatory approval.
MAVERIC is currently being initiated at pre-eminent cardiovascular clinical research sites throughout the United States under an Investigational New Drug application authorized by the United States Food and Drug Administration ('US FDA'). The MAVERIC Program and Phase III leadership comprises an independent committee of international thought leaders in pericardial disease and clinical trial design: Allan Klein, MD, CM from Cleveland Clinic (MAVERIC Program Chair); Massimo Imazio, MD, FESC from University of Udine, Italy (MAVERIC Program Co-Chair); Paul Cremer, MD from Northwestern University (MAVERIC Trial Principal Investigator); Allen Luis, MBBS, PhD from Mayo Clinic Rochester (MAvERIC-Pilot Principal Investigator); Antonio Abbate, MD, PhD from University of Virginia; and, Stephen Nicholls, MBBS, PhD from Monash University, Melbourne, Australia.
'Recurrent pericarditis remains a challenging condition to manage and can significantly impact patients' quality of life. There is a pressing need for new treatment options earlier in the care pathway, before resorting to second- and third-line therapies such as corticosteroids or IL-1 blockers,' commented Paul C. Cremer, MD, MAVERIC Trial Principal Investigator. 'In collaboration with research centers across the United States, Canada, and Europe, we look forward to completing this important study of a new oral therapy with the potential to improve the treatment paradigm for this underserved patient population.'
'Initiation of the MAVERIC Phase III trial is an important milestone in our Company's efforts to provide a more accessible, non-immunosuppressive therapeutic option for thousands of pericarditis patients. We congratulate Dr. Cremer and his colleagues at Northwestern for recruiting MAVERIC's first patient and we are grateful for the interest shown by our collaborators from other leading pericardial disease centers who will be participating in the study,' said David Elsley, President and CEO of Cardiol Therapeutics. 'Based on the strength and consistency of the data from our Phase II MAvERIC-Pilot study, we believe that CardiolRx™ can make a meaningful difference in the lives of pericarditis patients.'
MAVERIC is a Phase III, multi-center, randomized, double-blind, placebo-controlled trial designed to enroll 110 patients with recurrent pericarditis at approximately 20 clinical sites across the United States, Canada, and Europe. Patients who have been treated with an interleukin-1 ('IL-1") blocker for at least 12 months and are scheduled to have this treatment discontinued, will be randomly assigned to receive either CardiolRx™ or placebo following cessation of the IL-1 blocker. Discontinuation of IL-1 blocker therapy is associated with a high risk for recurrence and has been reported to occur within 12 weeks in up to 75% of patients. The primary clinical objective of the trial will be to assess the impact of CardiolRx™ versus placebo on freedom from a new episode of recurrent pericarditis at 24 weeks. Other clinical endpoints include time to a new episode of pericarditis recurrence, and changes in patient-reported pericarditis chest pain score and changes to the inflammatory marker C-reactive protein.
MAVERIC, formerly referred to as MAVERIC-2, follows positive results from Cardiol's Phase II MAvERIC-Pilot study. Data from MAvERIC-Pilot were previously reported on November 18 at the American Heart Association Scientific Sessions 2024 and showed that patients experienced marked and rapid reductions in both pericarditis pain and inflammation that were maintained throughout the study. In addition, the results demonstrated a substantial reduction in pericarditis episodes per year. Treatment with CardiolRx™ was shown to be safe and well tolerated in a patient population who presented with a high degree of disease burden.
About Pericarditis
Pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart), which frequently results from a viral infection. Patients may have multiple recurrences following that initial episode, and the primary goal of treatment is recurrence prevention. Symptoms include debilitating chest pain, shortness of breath and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. On an annual basis, the number of patients in the United States experiencing at least one recurrence is estimated at 38,000. Approximately 60% of patients with more than one recurrence suffer for more than two years, and one third remain impacted at five years. Hospitalization due to recurrent pericarditis is typically associated with a 6-8-day stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The Company's lead small molecule drug candidate, CardiolRx™ (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
Cardiol has received Investigational New Drug Application authorization from the United States Food and Drug Administration ('US FDA') to conduct clinical studies to evaluate the efficacy and safety of CardiolRx™ in two diseases affecting the heart: recurrent pericarditis and acute myocarditis. The MAVERIC Program in recurrent pericarditis, an inflammatory disease of the pericardium which is associated with symptoms including debilitating chest pain, shortness of breath, and fatigue, and results in physical limitations, reduced quality of life, emergency department visits, and hospitalizations, comprises the completed Phase II MAvERIC-Pilot study (NCT05494788) and the ongoing Phase III MAVERIC trial (NCT06708299). The ongoing ARCHER trial (NCT05180240) is a Phase II study in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age. The US FDA has granted Orphan Drug Designation to CardiolRx™ for the treatment of pericarditis, which includes recurrent pericarditis.
Cardiol is also developing CRD-38, a novel subcutaneously administered drug formulation intended for use in heart failure - a leading cause of death and hospitalization in the developed world, with associated healthcare costs in the United States exceeding $30 billion annually.
For more information about Cardiol Therapeutics, please visit cardiolrx.com.
Cautionary statement regarding forward-looking information:For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
[email protected]
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/248691
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Warnings and PrecautionsCentral Nervous System DepressionThe concurrent use of XYWAV with other CNS depressants, including but not limited to opioid analgesics, benzodiazepines, sedating antidepressants or antipsychotics, sedating anti-epileptic drugs, general anesthetics, muscle relaxants, and/or illicit CNS depressants, may increase the risk of respiratory depression, hypotension, profound sedation, syncope, and death. If use of these CNS depressants in combination with XYWAV is required, dose reduction or discontinuation of one or more CNS depressants (including XYWAV) should be considered. In addition, if short-term use of an opioid (eg, post- or perioperative) is required, interruption of treatment with XYWAV should be considered. After first initiating treatment and until certain that XYWAV does not affect them adversely (eg, impair judgment, thinking, or motor skills), caution patients against hazardous activities requiring complete mental alertness or motor coordination such as operating hazardous machinery, including automobiles or airplanes. Also caution patients against these hazardous activities for at least 6 hours after taking XYWAV. Patients should be queried about CNS depression-related events upon initiation of XYWAV therapy and periodically thereafter. Abuse and MisuseXYWAV is a Schedule Ill controlled substance. The active moiety of XYWAV is oxybate, also known as gamma-hydroxybutyrate (GHB), a Schedule I controlled substance. Abuse of illicit GHB, either alone or in combination with other CNS depressants, is associated with CNS adverse reactions, including seizure, respiratory depression, decreases in the level of consciousness, coma, and death. The rapid onset of sedation, coupled with the amnestic features of GHB particularly when combined with alcohol, has proven to be dangerous for the voluntary and involuntary user (eg, assault victim). Physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely. XYWAV and XYREM REMSBecause of the risks of central nervous system depression and abuse and misuse, XYWAV is available only through a restricted distribution program called the XYWAV and XYREM REMS. Notable requirements of the XYWAV and XYREM REMS include the following: Healthcare Providers who prescribe XYWAV are specially certified XYWAV will be dispensed only by the central pharmacy that is specially certified XYWAV will be dispensed and shipped only to patients who are enrolled in the XYWAV and XYREM REMS with documentation of safe use Further information is available at or 1-866-997-3688. Respiratory Depression and Sleep-Disordered BreathingXYWAV may impair respiratory drive, especially in patients with compromised respiratory function. In overdoses of oxybate and with illicit use of GHB, life-threatening respiratory depression has been reported. Increased apnea and reduced oxygenation may occur with XYWAV administration in adult and pediatric patients. A significant increase in the number of central apneas and clinically significant oxygen desaturation may occur in patients with obstructive sleep apnea treated with XYWAV. Prescribers should be aware that sleep-related breathing disorders tend to be more prevalent in obese patients, in men, in postmenopausal women not on hormone replacement therapy, and among patients with narcolepsy. Depression and SuicidalityIn Study 1, the randomized-withdrawal clinical trial in adult patients with narcolepsy (n=201), depression and depressed mood were reported in 3% and 4%, respectively, of patients treated with XYWAV. Two patients (1%) discontinued XYWAV because of depression. In most cases, no change in XYWAV treatment was required. In Study 2, the randomized-withdrawal clinical trial in adult patients with idiopathic hypersomnia (n=154), depression and depressed mood were reported in 1% and 3%, respectively, of patients treated with XYWAV. All patients continued XYWAV treatment. Two suicides and two attempted suicides occurred in adult clinical trials with oxybate (same active moiety as XYWAV). One patient experienced suicidal ideation and two patients reported depression in a pediatric clinical trial with oxybate. These events occurred in patients with and without previous histories of depressive disorders. The emergence of depression in patients treated with XYWAV requires careful and immediate evaluation. Monitor patients for the emergence of increased depressive symptoms and/or suicidality while taking XYWAV. Other Behavioral or Psychiatric Adverse ReactionsIn Study 1, confusion and anxiety occurred in 1% and 5% of patients with narcolepsy treated with XYWAV, respectively. One patient experienced visual hallucinations and confusion after ingesting approximately 9 grams of XYWAV. In Study 2, confusion and anxiety occurred in 3% and 16% of patients with idiopathic hypersomnia, respectively. One patient experienced visual hallucinations, which led to discontinuation of XYWAV. Other neuropsychiatric reactions reported with oxybate (same active moiety as XYWAV) in adult or pediatric clinical trials and in the postmarketing setting include hallucinations, paranoia, psychosis, aggression, agitation, confusion and anxiety. The emergence or increase in the occurrence of behavioral or psychiatric events in patients taking XYWAV should be carefully monitored. ParasomniasParasomnias can occur in patients taking XYWAV. In Study 1 and Study 2, parasomnias, including sleepwalking, were reported in 6% and 5% of adult patients treated with XYWAV, respectively. In a clinical trial of XYREM (same active moiety as XYWAV) in adult patients with narcolepsy, five instances of sleepwalking with potential injury or significant injury were reported. Parasomnias, including sleepwalking, have been reported in a pediatric clinical trial with sodium oxybate (same active moiety as XYWAV) and in postmarketing experience with sodium oxybate. Episodes of sleepwalking should be fully evaluated and appropriate interventions considered. Most Common Adverse ReactionsThe most common adverse reactions (occurring in ≥5% of XYWAV-treated patients in adult clinical trials in either narcolepsy or IH) were nausea, headache, dizziness, anxiety, insomnia, decreased appetite, hyperhidrosis, vomiting, diarrhea, dry mouth, parasomnia, somnolence, fatigue, and tremor. In the pediatric clinical trial with XYREM (same active moiety as XYWAV) that included pediatric patients 7 to 17 years of age with narcolepsy, the most common adverse reactions (≥5%) were nausea (20%), enuresis (19%), vomiting (18%), headache (17%), weight decreased (13%), decreased appetite (9%), dizziness (8%), and sleepwalking (6%). The overall adverse reaction profile of XYREM in the pediatric clinical trial was similar to that seen in the adult clinical trial program. The safety profile in pediatric patients with XYWAV is expected to be similar to that of adult patients treated with XYWAV and to that of pediatric patients treated with XYREM. Additional Adverse ReactionsAdverse reactions that occurred in 2-<5% of adult patients treated with XYWAV in the Open Label Titration and Stable Dose Periods of the randomized-withdrawal study in adult patients with narcolepsy with cataplexy (Study 1) were fatigue, dry mouth, depressed mood, enuresis, irritability, paresthesia, depression, tremor, somnolence, and muscle spasms. Adverse reactions occurring in 2-<5% of patients treated with XYWAV in the IH study include balance disorder, muscle spasms, fall, paresthesia, snoring, weight decreased, bruxism, confusional state, depressed mood, feeling drunk, and irritability. Adverse reactions that occurred in ≥2% of patients in clinical studies with oxybate (but not in Study 1) and which may be relevant for XYWAV, were pain, feeling drunk, pain in extremity, cataplexy, disturbance in attention, sleep paralysis, and disorientation. Discontinuation: In Study 1, 9 of 201 patients (4%) reported adverse reactions that led to withdrawal from the study (anxiety, decreased appetite, depressed mood, depression, fatigue, headache, irritability, nausea, pain in extremity, parasomnia, somnolence, and vomiting). The most common adverse reaction leading to discontinuation was nausea (1.5%). In Study 2, 17 of 154 (11%) patients across all study periods (excluding placebo during the DB RWP) (up to 42 weeks) reported adverse reactions that led to withdrawal from the study (anxiety, nausea, insomnia, vomiting, fatigue, feeling abnormal, fall, decreased appetite, dizziness, paresthesia, tremor, parasomnia, confusional state, hallucination visual, and irritability). The most common adverse reaction leading to discontinuation was anxiety (3.2%). In Study 1 and Study 2, the majority of adverse reactions leading to discontinuation began during the first few weeks of treatment. 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Pediatric UseThe safety and effectiveness of XYWAV for the treatment of cataplexy or excessive daytime sleepiness in pediatric patients 7 years of age and older with narcolepsy have been established. XYWAV has not been studied in a pediatric clinical trial for narcolepsy or IH. Use of XYWAV in pediatric patients 7 years of age and older with narcolepsy is supported by evidence from an adequate and well-controlled study of sodium oxybate in pediatric patients 7 to 17 years of age, a study in adults showing a treatment effect of XYWAV similar to that observed with sodium oxybate, pharmacokinetic data of sodium oxybate from adult and pediatric patients, and pharmacokinetic data of XYWAV from healthy adult volunteers. Safety and effectiveness of XYWAV in pediatric patients below the age of 7 years with narcolepsy have not been established. Safety and effectiveness of XYWAV for the treatment of idiopathic hypersomnia in pediatric patients have not been established. Geriatric UseIn general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Hepatic ImpairmentThe starting dose of XYWAV should be reduced in patients with liver impairment. Dosage Modification in Patients with Hepatic Impairment: The recommended starting dosage in patients with hepatic impairment is one-half of the original dosage per night, administered orally, divided into two doses. Dependence and ToleranceThere have been case reports of withdrawal, ranging from mild to severe, following discontinuation of illicit use of GHB at frequent repeated doses (18 g to 250 g per day) in excess of the recommended dosage range. Signs and symptoms of GHB withdrawal following abrupt discontinuation included insomnia, restlessness, anxiety, psychosis, lethargy, nausea, tremor, sweating, muscle cramps, tachycardia, headache, dizziness, rebound fatigue and sleepiness, confusion, and, particularly in the case of severe withdrawal, visual hallucinations, agitation, and delirium. These symptoms generally abated in 3 to 14 days. In cases of severe withdrawal, hospitalization may be required. In the clinical trial experience with XYREM in narcolepsy/cataplexy patients at recommended doses, two patients reported anxiety and one reported insomnia following abrupt discontinuation at the termination of the clinical trial; in the two patients with anxiety, the frequency of cataplexy had increased markedly at the same time. In the XYWAV clinical trial in adult narcolepsy/cataplexy patients at recommended doses, one patient reported insomnia following abrupt discontinuation of XYWAV. In the XYWAV clinical trial in adult idiopathic hypersomnia patients at recommended doses, six patients reported insomnia, two patients reported early insomnia, and one patient reported visual and auditory hallucinations following abrupt discontinuation of XYWAV. Tolerance to XYWAV has not been systematically studied in controlled clinical trials. There have been some case reports of symptoms of tolerance developing after illicit use at dosages far in excess of the recommended XYWAV dosage regimen. Please see full Prescribing Information, including BOXED Warning here: About Jazz PharmaceuticalsJazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Contacts: Media:Kristin BhavnaniHead of Global Corporate CommunicationsJazz Pharmaceuticals plcCorporateAffairsMediaInfo@ Ireland +353 1 637 2141U.S. +1 215 867 4948 Investors:Jeff MacdonaldExecutive Director, Investor RelationsJazz Pharmaceuticals plcInvestorInfo@ +353 1 634 3211U.S. +1 650 496 2717 References: Sateia, M. J. (2023). International Classification of Sleep Disorders-Third Edition, Text Revision (ICSD-3-TR). Chest, 146(5), 1387–1394. PubMed. Dauvilliers Y, Arnulf I, Mignot E. Narcolepsy with cataplexy. Lancet. 2007;369(9560):499-511. Colten HR, Altevogt BM, Institute of Medicine (US) Committee on Sleep Medicine and Research, eds. Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem. Washington (DC): National Academies Press (US); 2006. Peacock J, Benca RM. Narcolepsy: clinical features, co-morbidities & treatment. Indian Journal of Medical Research. 2010;131(2):338-349. National Health Service. Narcolepsy – Overview. 2019. Accessed June 2025. Ben-Joseph RH, Saad R, Black J, et al. Cardiovascular burden of narcolepsy disease (CV-BOND): a real-world evidence study. Presented at: 2022 AAN Annual Meeting; April 2-7; Seattle, Washington. Poster 1203. Black J, Reaven NL, Funk SE, et al. Medical comorbidity in narcolepsy: findings from the Burden of Narcolepsy Disease (BOND) study. Sleep Med. 2017;33:13-18. Ohayon MM, Black J, Lai C, et al. Increased mortality in narcolepsy. Sleep. 2014;37(3):439-444. Ohayon MM. Narcolepsy is complicated by high medical and psychiatric comorbidities: a comparison with the general population. Sleep Med. 2013;14(6):488-492. Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution. Prescribing Information. Palo Alto, CA: Jazz Pharmaceuticals, Inc. 2021. United States Drug Enforcement Agency. Drug Scheduling. Accessed June 2025. View original content to download multimedia: SOURCE Jazz Pharmaceuticals plc Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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MochaLean Announces Official Website Update Featuring Natural Daily Supplement for Weight Management Support
New U.S.-Available Metabolism Support Supplement Designed to Promote Appetite Control and Daily Energy Balance Naturally TALLMADGE, June 09, 2025 (GLOBE NEWSWIRE) -- MochaLean™, a U.S.-based wellness brand, has updated its official website to share new information about its daily supplement developed to support healthy weight management in adults. Now available in the U.S., the plant-based formula is designed for individuals seeking a natural, routine-friendly wellness solution. According to the official product website ( MochaLean™ is intended to work in harmony with the body's internal systems to support metabolism, appetite regulation, and energy levels. The company positions the supplement as a convenient, daily-use formula that integrates into everyday life without requiring restrictive diets or complicated routines. 'We believe health support should be simple and natural,' said a company spokesperson. 'This product reflects our commitment to natural wellness and quality-driven formulation.' The company states that MochaLean™ is manufactured in facilities that follow strict safety and quality control protocols. The formulation is composed of ingredients selected to align with common adult wellness goals, such as metabolic support, healthy energy maintenance, and appetite balance. As noted on the product website, MochaLean™ includes a satisfaction guarantee for new customers. Those interested in exploring the formula's intended uses or ordering directly can find full details, FAQs, and purchasing options at the official site. About MochaLean™ MochaLean™ is a U.S.-based wellness brand focused on delivering natural, easy-to-use supplements that support daily health routines. Committed to transparency and simplicity, the company aims to provide effective solutions that help adults feel their best. Product and Contact Information Brand: MochaLean™Website: support@ 1-800-390-6035Return Address: Fulfillment House, 285 Northeast Ave, Tallmadge, OH 44278, USA Disclaimer This release is for informational purposes only and does not constitute medical advice, diagnosis, or treatment. The statements made about this product have not been evaluated by the Food and Drug Administration. Individual results may vary. Consumers should consult a qualified healthcare provider before beginning any new dietary supplement. CONTACT: Email: support@ Phone: 1-800-390-6035 Return Address: Fulfillment House, 285 Northeast Ave, Tallmadge, OH 44278, USA
