Cardiol Therapeutics Announces Database Lock for Phase II ARCHER Trial of CardiolRx(TM) in Acute Myocarditis
Cardiol Therapeutics (NASDAQ: CRDL) has announced the database lock for its Phase II ARCHER trial investigating CardiolRx™ in acute myocarditis patients. The trial, which enrolled over 100 patients across research centers in the United States, France, Brazil, and Israel, is a multi-national, randomized, double-blind, placebo-controlled study.
The study's primary outcome measures evaluate cardiac magnetic resonance imaging parameters after 12 weeks of therapy, focusing on global longitudinal strain and extra-cellular volume. These parameters are crucial prognostic markers for myocarditis patients. Topline results are expected within two weeks of the database lock.
Notably, acute myocarditis currently has no FDA-approved drug therapies. The condition results in an average seven-day hospital stay with 4-6% in-hospital mortality risk, costing approximately $110,000 per stay in the United States.
Cardiol Therapeutics (NASDAQ: CRDL) ha annunciato il blocco del database per il suo trial di Fase II ARCHER, che indaga l'efficacia di CardiolRx™ nei pazienti con miocardite acuta. Lo studio, che ha arruolato oltre 100 pazienti in centri di ricerca negli Stati Uniti, Francia, Brasile e Israele, è uno studio multinazionale, randomizzato, in doppio cieco e controllato con placebo.
Gli esiti primari dello studio valutano i parametri di risonanza magnetica cardiaca dopo 12 settimane di terapia, concentrandosi sullo strain longitudinale globale e sul volume extracellulare. Questi parametri rappresentano importanti marcatori prognostici per i pazienti con miocardite. I risultati principali sono attesi entro due settimane dal blocco del database.
È importante sottolineare che attualmente per la miocardite acuta non esistono terapie farmacologiche approvate dalla FDA. La condizione comporta una degenza ospedaliera media di sette giorni con un rischio di mortalità in ospedale del 4-6%, e un costo di circa 110.000 dollari per ricovero negli Stati Uniti.
Cardiol Therapeutics (NASDAQ: CRDL) ha anunciado el cierre de la base de datos para su ensayo de Fase II ARCHER, que investiga CardiolRx™ en pacientes con miocarditis aguda. El ensayo, que reclutó a más de 100 pacientes en centros de investigación de Estados Unidos, Francia, Brasil e Israel, es un estudio multinacional, aleatorizado, doble ciego y controlado con placebo.
Las medidas principales del estudio evalúan parámetros de resonancia magnética cardíaca después de 12 semanas de tratamiento, centrándose en la deformación longitudinal global y el volumen extracelular. Estos parámetros son marcadores pronósticos clave para los pacientes con miocarditis. Se esperan resultados principales dentro de dos semanas tras el cierre de la base de datos.
Es importante destacar que actualmente no existen terapias farmacológicas aprobadas por la FDA para la miocarditis aguda. La condición implica una estancia hospitalaria promedio de siete días con un riesgo de mortalidad hospitalaria del 4-6%, con un costo aproximado de 110,000 dólares por estancia en Estados Unidos.
Cardiol Therapeutics (NASDAQ: CRDL)는 급성 심근염 환자를 대상으로 한 CardiolRx™의 2상 ARCHER 임상시험 데이터베이스 잠금 완료를 발표했습니다. 미국, 프랑스, 브라질, 이스라엘의 연구 센터에서 100명 이상의 환자가 등록된 이 다국적, 무작위 배정, 이중 맹검, 위약 대조 연구입니다.
연구의 주요 결과 지표는 12주 치료 후 심장 자기공명영상(MRI) 파라미터를 평가하며, 전반적인 종축 변형률과 세포외 부피에 중점을 둡니다. 이 지표들은 심근염 환자에게 중요한 예후 인자입니다. 데이터베이스 잠금 후 2주 이내에 주요 결과가 발표될 예정입니다.
특히, 급성 심근염에 대해 현재 FDA 승인 약물 치료법이 없습니다. 이 질환은 평균 7일간의 입원 기간과 4-6%의 입원 중 사망률 위험을 동반하며, 미국 내 입원당 약 11만 달러의 비용이 발생합니다.
Cardiol Therapeutics (NASDAQ : CRDL) a annoncé le verrouillage de la base de données pour son essai de phase II ARCHER, qui étudie CardiolRx™ chez les patients atteints de myocardite aiguë. L'essai, qui a recruté plus de 100 patients dans des centres de recherche aux États-Unis, en France, au Brésil et en Israël, est une étude multinationale, randomisée, en double aveugle et contrôlée par placebo.
Les critères d'évaluation principaux de l'étude examinent les paramètres d'imagerie par résonance magnétique cardiaque après 12 semaines de traitement, en se concentrant sur la déformation longitudinale globale et le volume extracellulaire. Ces paramètres sont des marqueurs pronostiques essentiels pour les patients atteints de myocardite. Les résultats principaux sont attendus dans un délai de deux semaines après le verrouillage de la base de données.
Il est important de noter qu'il n'existe actuellement aucun traitement médicamenteux approuvé par la FDA pour la myocardite aiguë. Cette maladie entraîne une hospitalisation moyenne de sept jours avec un risque de mortalité hospitalière de 4 à 6 % et un coût d'environ 110 000 dollars par séjour aux États-Unis.
Cardiol Therapeutics (NASDAQ: CRDL) hat den Datenbankverschluss für seine Phase-II-ARCHER-Studie bekanntgegeben, die CardiolRx™ bei Patienten mit akuter Myokarditis untersucht. Die Studie, an der über 100 Patienten in Forschungszentren in den USA, Frankreich, Brasilien und Israel teilnahmen, ist eine multinationale, randomisierte, doppelblinde, placebokontrollierte Studie.
Die primären Endpunkte der Studie bewerten kardiale Magnetresonanztomographie-Parameter nach 12 Wochen Therapie, mit Fokus auf globalen longitudinalen Strain und extrazelluläres Volumen. Diese Parameter sind wichtige prognostische Marker für Myokarditis-Patienten. Die Hauptergebnisse werden innerhalb von zwei Wochen nach Datenbankverschluss erwartet.
Bemerkenswert ist, dass es derzeit keine von der FDA zugelassenen medikamentösen Therapien für akute Myokarditis gibt. Die Erkrankung führt zu einem durchschnittlichen Krankenhausaufenthalt von sieben Tagen mit einem 4-6%igen Sterberisiko im Krankenhaus und verursacht Kosten von etwa 110.000 US-Dollar pro Aufenthalt in den USA.
- None.
- Final trial results not yet available
- Competitive landscape and market potential remain uncertain
- Phase II stage indicates several years before potential commercialization
Insights
Cardiol's Phase II ARCHER trial of CardiolRx reaches critical database lock milestone, with topline results expected within two weeks.
Cardiol Therapeutics has reached a significant clinical development milestone with the database lock for their Phase II ARCHER trial investigating CardiolRx for acute myocarditis. This procedural step marks the completion of data collection and cleaning, allowing the company to now proceed with statistical analysis and unblinding of results.
The trial enrolled over 100 patients across multiple countries and is designed to evaluate CardiolRx's impact on two critical cardiac MRI parameters: global longitudinal strain and extra-cellular volume. These measurements are particularly valuable as they assess both cardiac function and tissue characteristics related to inflammation and fibrosis – both central to myocarditis pathology and patient prognosis.
This news carries substantial significance as acute myocarditis represents a serious unmet medical need with no FDA-approved therapies. The condition can be life-threatening, leading to heart failure or sudden cardiac death, particularly in young adults. Hospitalization for acute myocarditis carries a concerning 4-6% in-hospital mortality rate with substantial healthcare costs (estimated
The impending data readout in approximately two weeks will provide critical insights not only for the ARCHER program but also potentially inform Cardiol's ongoing pivotal Phase III MAVERIC trial in recurrent pericarditis. Management has indicated that ARCHER results could guide their broader development strategy for heart diseases where fibrosis plays a key role.
While this announcement itself doesn't provide efficacy signals, the successful completion of this milestone demonstrates operational execution and brings the company closer to understanding CardiolRx's potential in treating this serious cardiovascular condition.
ARCHER is designed to assess the impact of CardiolRx™ on cardiac magnetic resonance imaging parameters that measure heart dysfunction and edema/fibrosis-key measurements used to predict prognosis in myocarditis patients.
Acute myocarditis is a potentially life-threatening condition affecting the heart muscle (myocardium) and is characterized by chest pain, shortness of breath, fatigue, rapid or irregular heartbeat (arrhythmias), and light-headedness, and can lead to heart failure or sudden cardiac death.
There are no FDA-approved drug therapies indicated for the treatment of acute myocarditis.
Topline results are expected within the next two weeks.
Toronto, Ontario--(Newsfile Corp. - July 22, 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, today announced database lock for ARCHER, the Company's Phase II multi-national, randomized, double-blind, placebo-controlled trial investigating its lead asset, CardiolRx™, on myocardial recovery in patients with acute myocarditis.
"Database lock marks another important milestone in the ARCHER program, enabling statistical analysis, unblinding, and the reporting of topline results, which are now expected within the next two weeks," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics. "As we advance our lead program—the pivotal Phase III MAVERIC trial of CardiolRx™ in recurrent pericarditis—we believe results from ARCHER will further guide our broader development strategy in forms of heart disease where fibrosis plays a key role."
Dr. Andrew Hamer, Cardiol Therapeutics' Chief Medical Officer and Head of Research & Development, added, "Acute myocarditis remains a serious and underserved cardiovascular condition with no approved pharmacological therapy, underscoring the significance of ARCHER. On behalf of the ARCHER Steering Committee and Cardiol Therapeutics, I would like to thank our clinical investigators and the patients and their families for their essential contributions. We look forward to receiving the results of the statistical analysis, which we believe will provide important insights into the effects of CardiolRx™ on MRI-based measures of cardiac fibrosis and function in patients with myocarditis."
ARCHER is a Phase II multi-national, randomized, double-blind, placebo-controlled trial investigating the safety, tolerability, and impact of CardiolRx™ on myocardial recovery in patients presenting with acute myocarditis. The design and rationale for ARCHER were published on June 27, 2024, in the journal ESC Heart Failure. The study enrolled over 100 patients from leading cardiovascular research centers in the United States, France, Brazil, and Israel. The two primary outcome measures of the trial, which were evaluated following 12 weeks of double-blind therapy, consist of cardiac magnetic resonance imaging parameters: global longitudinal strain and extra-cellular volume, which assess myocardial function and tissue characteristics associated with fibrosis and inflammation. Both parameters are recognized prognostic markers in patients with acute myocarditis.
Acute Myocarditis
Acute myocarditis is an inflammatory condition of the heart muscle (myocardium) characterized by chest pain, shortness of breath at rest or during activity, fatigue, rapid or irregular heartbeat (arrhythmias), and light-headedness or the feeling one might faint. The disease is an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people under 35 years of age. Viral infection is the most common cause of myocarditis; however, it can also result from bacterial infection, commonly used drugs, and mRNA vaccines, as well as therapies used to treat several common cancers, including chemo-therapeutic agents and immune checkpoint inhibitors. There are no FDA-approved drug therapies for acute myocarditis. Patients hospitalized with the condition experience an average seven-day length of stay and a 4 -
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 Company's intended clinical studies and trial activities and timelines associated with 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 Company's preparation for statistical analysis, unblinding, and reporting of top-line results from its Phase II ARCHER trial of CardiolRx™ in acute myocarditis, and the Company's belief that results from the ARCHER trial will provide insights to help guide its broader development strategy in forms of heart disease where fibrosis plays a key role, and into the effects of CardiolRx™ on MRI-based measures of cardiac fibrosis and function in patients with myocarditis. 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 and clinical studies. 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.
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/259556
FAQ
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