Cardiol Therapeutics Enrolls First Patient in Pivotal Phase III MAVERIC Trial in Recurrent Pericarditis
Cardiol Therapeutics (NASDAQ: CRDL) has initiated its pivotal Phase III MAVERIC trial by enrolling the first patient at Northwestern University, evaluating CardiolRx™ for preventing recurrent pericarditis. The multi-center, randomized, double-blind, placebo-controlled trial will enroll 110 patients across the US, Canada, and Europe.
The trial follows positive Phase II MAvERIC-Pilot results presented at AHA Scientific Sessions 2024, which demonstrated marked reductions in pericarditis pain, inflammation, and yearly recurrences. CardiolRx™, granted FDA Orphan Drug Designation, is an oral drug targeting the inflammasome pathway.
MAVERIC will assess patients who have been treated with IL-1 blockers for at least 12 months and are scheduled to discontinue treatment. The primary endpoint is freedom from pericarditis recurrence at 24 weeks. The study is being conducted at approximately 20 clinical sites under FDA-authorized IND application.
Cardiol Therapeutics (NASDAQ: CRDL) ha avviato il suo studio cardine di Fase III MAVERIC, arruolando il primo paziente alla Northwestern University, per valutare CardiolRx™ nella prevenzione della pericardite recidivante. Lo studio multicentrico, randomizzato, in doppio cieco e controllato con placebo arruolerà 110 pazienti negli Stati Uniti, Canada ed Europa.
La sperimentazione segue i risultati positivi della Fase II MAvERIC-Pilot presentati alle AHA Scientific Sessions 2024, che hanno mostrato una significativa riduzione del dolore, dell'infiammazione e delle recidive annue di pericardite. CardiolRx™, designato come farmaco orfano dalla FDA, è un farmaco orale che agisce sul pathway dell'inflammasoma.
MAVERIC valuterà pazienti trattati con bloccanti IL-1 per almeno 12 mesi e programmati per interrompere la terapia. L'endpoint primario è l'assenza di recidive di pericardite a 24 settimane. Lo studio si svolge in circa 20 centri clinici autorizzati dalla FDA tramite IND.
Cardiol Therapeutics (NASDAQ: CRDL) ha iniciado su ensayo pivotal de Fase III MAVERIC inscribiendo al primer paciente en la Northwestern University, evaluando CardiolRx™ para la prevención de la pericarditis recurrente. El ensayo multicéntrico, aleatorizado, doble ciego y controlado con placebo reclutará a 110 pacientes en EE.UU., Canadá y Europa.
El estudio sigue los resultados positivos de la Fase II MAvERIC-Pilot presentados en las AHA Scientific Sessions 2024, que demostraron reducciones significativas en el dolor, inflamación y recurrencias anuales de pericarditis. CardiolRx™, designado como medicamento huérfano por la FDA, es un fármaco oral que actúa sobre la vía del inflamasoma.
MAVERIC evaluará a pacientes tratados con bloqueadores de IL-1 durante al menos 12 meses y que están programados para interrumpir el tratamiento. El objetivo principal es la ausencia de recurrencia de pericarditis a las 24 semanas. El estudio se realiza en aproximadamente 20 centros clínicos bajo una aplicación IND autorizada por la FDA.
Cardiol Therapeutics (NASDAQ: CRDL)는 Northwestern University에서 첫 환자를 등록하며 중추적인 3상 임상시험 MAVERIC을 시작했습니다. 이 연구는 재발성 심낭염 예방을 위해 CardiolRx™를 평가합니다. 다기관, 무작위 배정, 이중맹검, 위약 대조 시험으로 미국, 캐나다, 유럽에서 총 110명의 환자를 모집할 예정입니다.
이 임상은 2024년 AHA Scientific Sessions에서 발표된 긍정적인 2상 MAvERIC-Pilot 결과를 바탕으로 진행되며, 심낭염 통증, 염증 및 연간 재발률이 현저히 감소했음을 보여주었습니다. FDA 희귀의약품 지정 받은 CardiolRx™는 염증복합체 경로를 타겟으로 하는 경구 약물입니다.
MAVERIC은 최소 12개월 이상 IL-1 차단제로 치료받고 치료 중단 예정인 환자를 평가합니다. 1차 평가변수는 24주 동안 심낭염 재발이 없는 상태입니다. 본 연구는 FDA 승인 IND 하에 약 20개 임상 사이트에서 진행 중입니다.
Cardiol Therapeutics (NASDAQ : CRDL) a lancé son essai pivot de phase III MAVERIC en recrutant le premier patient à la Northwestern University, évaluant CardiolRx™ pour la prévention de la péricardite récurrente. L'essai multicentrique, randomisé, en double aveugle et contrôlé par placebo, recrutera 110 patients aux États-Unis, au Canada et en Europe.
L'essai fait suite aux résultats positifs de la phase II MAvERIC-Pilot présentés aux AHA Scientific Sessions 2024, qui ont montré des réductions marquées de la douleur, de l'inflammation et des récidives annuelles de péricardite. CardiolRx™, désigné médicament orphelin par la FDA, est un médicament oral ciblant la voie de l'inflammasome.
MAVERIC évaluera des patients traités avec des bloqueurs IL-1 pendant au moins 12 mois et devant interrompre leur traitement. Le critère principal est l'absence de récidive de péricardite à 24 semaines. L'étude se déroule dans environ 20 centres cliniques sous une demande IND autorisée par la FDA.
Cardiol Therapeutics (NASDAQ: CRDL) hat die entscheidende Phase-III-Studie MAVERIC gestartet und den ersten Patienten an der Northwestern University eingeschlossen, um CardiolRx™ zur Vorbeugung von wiederkehrender Perikarditis zu evaluieren. Die multizentrische, randomisierte, doppelblinde, placebokontrollierte Studie wird 110 Patienten in den USA, Kanada und Europa einschließen.
Die Studie folgt auf positive Ergebnisse der Phase-II MAvERIC-Pilot, die auf den AHA Scientific Sessions 2024 vorgestellt wurden und deutliche Reduktionen von Perikarditis-Schmerzen, Entzündungen und jährlichen Rückfällen zeigten. CardiolRx™, das von der FDA als Orphan Drug zugelassen wurde, ist ein orales Medikament, das den Inflammasom-Weg gezielt hemmt.
MAVERIC wird Patienten untersuchen, die mindestens 12 Monate mit IL-1-Blockern behandelt wurden und deren Behandlung eingestellt werden soll. Der primäre Endpunkt ist das Ausbleiben eines Perikarditis-Rückfalls nach 24 Wochen. Die Studie wird an etwa 20 klinischen Standorten unter einer von der FDA genehmigten IND durchgeführt.
- FDA Orphan Drug Designation granted for CardiolRx™
- Successful Phase II results showing marked efficacy in reducing pericarditis symptoms
- Phase III trial initiation following successful FDA end-of-Phase II meeting
- Potential for New Drug Application based on MAVERIC outcomes
- 75% risk of disease recurrence within 12 weeks after IL-1 blocker discontinuation
Insights
The enrollment of MAVERIC's first patient represents a critical inflection point for Cardiol Therapeutics, signaling advancement into the final clinical development stage before potential commercialization. As a pivotal Phase III trial, MAVERIC will evaluate CardiolRx's ability to prevent recurrent pericarditis episodes in high-risk patients following IL-1 blocker discontinuation.
The study design demonstrates strategic positioning: 1) targeting patients transitioning off IL-1 blockers creates a well-defined high-risk population with up to 75% recurrence rates within 12 weeks, and 2) aiming to provide evidence for an oral therapy earlier in the treatment pathway before resorting to more complex biologics.
The Phase II MAvERIC-Pilot results strengthen this Phase III initiative, having demonstrated both rapid symptom reduction and decreased recurrence rates. Importantly, CardiolRx's Orphan Drug Designation could provide market exclusivity and accelerated review pathways if approved.
For a company with an $82.6M market cap, this milestone carries outsized significance. The multi-center trial involving 110 patients across 20 sites highlights Cardiol's ability to execute complex clinical development despite resource constraints. The primary endpoint of freedom from recurrence at 24 weeks offers a clear, clinically meaningful measure with potential regulatory acceptance.
The MAVERIC Phase III trial addresses a significant unmet need in recurrent pericarditis management. Current treatment pathways typically progress from NSAIDs and colchicine to corticosteroids and finally IL-1 blockers, with each step carrying increased side effect burdens. CardiolRx's mechanism targeting inflammasome pathway activation is particularly relevant as this pathway is central to pericarditis development and progression.
The trial's focus on patients discontinuing IL-1 blockers is clinically sophisticated. These patients face a 75% recurrence risk within 12 weeks of cessation, creating a clear window to demonstrate efficacy. This population also represents patients with the most challenging disease burden who have options once IL-1 blockers are discontinued.
The preliminary Phase II results showed both pain reduction and decreased inflammation markers, suggesting dual symptom and disease-modifying potential. The new Phase III's leadership team includes respected pericarditis experts like Dr. Klein (Cleveland Clinic) and Dr. Imazio (University of Udine), lending scientific credibility.
If successful, CardiolRx could fundamentally alter the treatment algorithm for recurrent pericarditis as a non-immunosuppressive oral option—potentially allowing earlier intervention before patients require biologics. The focus on patient-reported outcomes alongside inflammatory markers acknowledges the significant quality-of-life impact this condition has on sufferers.
Designed to assess the impact of CardiolRx™ on preventing episodes of recurrent pericarditis, the first patient has been randomized by Northwestern University in Chicago.
Based on a successful end-of-Phase II meeting with the US FDA and subject to MAVERIC outcomes, Cardiol believes the results from MAVERIC will support a New Drug Application.
Data from Cardiol's Phase II MAvERIC-Pilot study presented at the American Heart Association Scientific Sessions 2024 showed that pericarditis patients treated with CardiolRx™ experienced marked and rapid reductions in pericarditis pain and inflammation, and a substantial reduction in the number of pericarditis recurrences per year.
Recurrent pericarditis is a debilitating heart condition that results in chest pain, shortness of breath and fatigue, physical limitations, reduced quality of life, and hospitalizations.
CardiolRx™, which has been granted US FDA Orphan Drug Designation for this indication, is a small molecule oral drug targeting inflammasome pathway activation that is central to the development and progression of 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
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
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
For more information about Cardiol Therapeutics, please visit cardiolrx.com.
Cautionary statement regarding forward-looking information:
This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward looking information contained herein may include, but is not limited to statements regarding the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, the molecular targets and mechanism of action of the Company's product candidates, the Company's intended clinical studies and trial activities, timelines associated with such activities, and potential success of such activities, including the Company's plan to complete the Phase III study in recurrent pericarditis with CardiolRx, the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure, the newly published data providing additional important rationale for the development of CRD-38 as a new approach to the treatment of heart failure, and the JACBTS publication provides fascinating new data that suggest a key mode of action of CRD-38 to potentially treat heart failure is through its ability to sustain cardiomyocytes and preserve mitochondrial function. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Information Form filed with the Canadian securities administrators and U.S. Securities and Exchange Commission on March 31, 2025 , available on SEDAR+ at sedarplus.ca and EDGAR at sec.gov, as well as the risks and uncertainties associated with product commercialization, regulatory approvals, clinical studies and uncertainties in predicting treatment outcomes. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information, and such information may not be appropriate for other purposes. Any forward-looking information speaks only as of the date of this press release and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Company's Annual Information Form filed on March 31, 2025.
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/248691
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