Cardiol Therapeutics Announces Publication of Research in the Journal of the American College of Cardiology: Basic to Translational Science That Supports Development of Its Proprietary Subcutaneous Drug Candidate, CRD-38, for the Treatment of Heart Failure
Cardiol Therapeutics (NASDAQ: CRDL) announced the publication of research in the Journal of the American College of Cardiology: Basic to Translational Science supporting their subcutaneous drug candidate CRD-38 for heart failure treatment. The research, conducted by scientists from Tecnológico de Monterrey and DeBakey Heart and Vascular Center, demonstrates that subcutaneously administered cannabidiol improves cardiac function and reduces cardiac hypertrophy, remodeling, inflammation, and cell death.
The study results show that CRD-38 provides cardioprotection through multiple mechanisms, including preservation of mitochondrial function and calcium handling in heart cells. The research utilized multiple heart failure models, including in vivo, ex vivo, and in vitro investigations. Key findings revealed that the drug's cardioprotective effect may depend on PPAR-γ activation, which helps prevent mitochondrial dysfunction.
This research is particularly significant as heart failure with preserved ejection fraction remains a leading cause of hospitalization worldwide, with a five-year mortality exceeding 75% in hospitalized patients.
Cardiol Therapeutics (NASDAQ: CRDL) ha annunciato la pubblicazione di una ricerca nel Journal of the American College of Cardiology: Basic to Translational Science che supporta il loro candidato farmaco sottocutaneo CRD-38 per il trattamento dell'insufficienza cardiaca. La ricerca, condotta da scienziati del Tecnológico de Monterrey e del DeBakey Heart and Vascular Center, dimostra che il cannabidiolo somministrato sottocutaneamente migliora la funzione cardiaca e riduce l'ipertrofia cardiaca, il rimodellamento, l'infiammazione e la morte cellulare.
I risultati dello studio mostrano che CRD-38 fornisce cardioprotezione attraverso molteplici meccanismi, inclusa la preservazione della funzione mitocondriale e la gestione del calcio nelle cellule cardiache. La ricerca ha utilizzato molteplici modelli di insufficienza cardiaca, comprese indagini in vivo, ex vivo e in vitro. I principali risultati hanno rivelato che l'effetto cardioprotettivo del farmaco potrebbe dipendere dall'attivazione di PPAR-γ, che aiuta a prevenire la disfunzione mitocondriale.
Questa ricerca è particolarmente significativa poiché l'insufficienza cardiaca con frazione di eiezione preservata rimane una delle principali cause di ospedalizzazione a livello mondiale, con una mortalità a cinque anni che supera il 75% nei pazienti ospedalizzati.
Cardiol Therapeutics (NASDAQ: CRDL) anunció la publicación de una investigación en el Journal of the American College of Cardiology: Basic to Translational Science que apoya su candidato a fármaco subcutáneo CRD-38 para el tratamiento de la insuficiencia cardíaca. La investigación, realizada por científicos del Tecnológico de Monterrey y del DeBakey Heart and Vascular Center, demuestra que el cannabidiol administrado subcutáneamente mejora la función cardíaca y reduce la hipertrofia cardíaca, la remodelación, la inflamación y la muerte celular.
Los resultados del estudio muestran que CRD-38 proporciona cardioprotección a través de múltiples mecanismos, incluida la preservación de la función mitocondrial y el manejo del calcio en las células cardíacas. La investigación utilizó múltiples modelos de insuficiencia cardíaca, incluidas investigaciones in vivo, ex vivo e in vitro. Los hallazgos clave revelaron que el efecto cardioprotector del fármaco puede depender de la activación de PPAR-γ, que ayuda a prevenir la disfunción mitocondrial.
Esta investigación es particularmente significativa, ya que la insuficiencia cardíaca con fracción de eyección preservada sigue siendo una de las principales causas de hospitalización en todo el mundo, con una mortalidad a cinco años que supera el 75% en pacientes hospitalizados.
Cardiol Therapeutics (NASDAQ: CRDL)는 심부전 치료를 위한 피하 약물 후보인 CRD-38에 대한 연구 결과를 Journal of the American College of Cardiology: Basic to Translational Science에 발표했다고 발표했습니다. Tecnológico de Monterrey와 DeBakey Heart and Vascular Center의 과학자들이 수행한 이 연구는 피하로 투여된 칸나비디올이 심장 기능을 개선하고 심장 비대, 재형성, 염증 및 세포 사멸을 줄인다는 것을 보여줍니다.
연구 결과에 따르면 CRD-38은 미토콘드리아 기능과 심장 세포의 칼슘 조절을 포함한 여러 메커니즘을 통해 심장 보호 효과를 제공합니다. 연구는 in vivo, ex vivo 및 in vitro 조사를 포함한 여러 심부전 모델을 사용했습니다. 주요 발견은 약물의 심장 보호 효과가 미토콘드리아 기능 장애를 예방하는 데 도움이 되는 PPAR-γ 활성화에 의존할 수 있음을 보여주었습니다.
이 연구는 보존된 박출 분율을 가진 심부전이 전 세계적으로 입원 원인 중 하나로 남아 있으며, 입원 환자의 5년 사망률이 75%를 초과한다는 점에서 특히 중요합니다.
Cardiol Therapeutics (NASDAQ: CRDL) a annoncé la publication d'une recherche dans le Journal of the American College of Cardiology: Basic to Translational Science soutenant leur candidat médicament sous-cutané CRD-38 pour le traitement de l'insuffisance cardiaque. La recherche, réalisée par des scientifiques du Tecnológico de Monterrey et du DeBakey Heart and Vascular Center, démontre que le cannabidiol administré par voie sous-cutanée améliore la fonction cardiaque et réduit l'hypertrophie cardiaque, le remodelage, l'inflammation et la mort cellulaire.
Les résultats de l'étude montrent que CRD-38 fournit une cardioprotection par plusieurs mécanismes, notamment la préservation de la fonction mitochondriale et la gestion du calcium dans les cellules cardiaques. La recherche a utilisé plusieurs modèles d'insuffisance cardiaque, y compris des investigations in vivo, ex vivo et in vitro. Les principales conclusions ont révélé que l'effet cardioprotecteur du médicament pourrait dépendre de l'activation de PPAR-γ, qui aide à prévenir la dysfonction mitochondriale.
Cette recherche est particulièrement significative car l'insuffisance cardiaque avec fraction d'éjection préservée reste une cause majeure d'hospitalisation dans le monde, avec une mortalité à cinq ans dépassant 75 % chez les patients hospitalisés.
Cardiol Therapeutics (NASDAQ: CRDL) gab die Veröffentlichung von Forschungen im Journal of the American College of Cardiology: Basic to Translational Science bekannt, die ihren subkutanen Arzneimittelkandidaten CRD-38 zur Behandlung von Herzinsuffizienz unterstützen. Die von Wissenschaftlern des Tecnológico de Monterrey und des DeBakey Heart and Vascular Center durchgeführte Forschung zeigt, dass subkutan verabreichtes Cannabidiol die Herzfunktion verbessert und die Herzhypertrophie, Umgestaltung, Entzündung und Zellsterben reduziert.
Die Studienergebnisse zeigen, dass CRD-38 durch mehrere Mechanismen kardioprotektive Eigenschaften bietet, einschließlich der Erhaltung der mitochondrialen Funktion und der Kalziumregulation in Herzmuskelzellen. Die Forschung nutzte mehrere Modelle der Herzinsuffizienz, einschließlich in vivo, ex vivo und in vitro Untersuchungen. Wichtige Ergebnisse zeigten, dass die kardioprotektive Wirkung des Medikaments möglicherweise von der Aktivierung von PPAR-γ abhängt, die hilft, mitochondriale Dysfunktion zu verhindern.
Diese Forschung ist besonders bedeutend, da Herzinsuffizienz mit erhaltener Ejektionsfraktion weltweit eine der häufigsten Ursachen für Krankenhausaufenthalte bleibt, mit einer fünfjährigen Sterblichkeit von über 75 % bei hospitalisierten Patienten.
- Publication in prestigious JACC journal validates scientific credibility
- Successful preclinical results showing multiple therapeutic benefits
- Drug demonstrates cardioprotective effects through multiple mechanisms
- Targeting a significant market with high mortality rates (75% in 5 years)
- Drug candidate still in pre-clinical phase, requiring IND-enabling work
- No clinical trial data available yet
- Long development timeline ahead before potential commercialization
Insights
The publication in the Journal of the American College of Cardiology: Basic to Translational Science represents a significant scientific validation for Cardiol Therapeutics' CRD-38 program. The research reveals multiple mechanisms of action that could position CRD-38 as a potentially groundbreaking treatment for heart failure with preserved ejection fraction (HFpEF).
The study's findings are particularly noteworthy for several reasons:
- The demonstrated improvement in cardiac function and reduction in cardiac hypertrophy addresses core pathological processes in heart failure
- The preservation of mitochondrial function through PPAR-γ activation represents a novel therapeutic approach
- The subcutaneous administration route could offer significant advantages over oral formulations in terms of bioavailability and patient compliance
The research's comprehensive approach using multiple models provides robust preclinical evidence. The demonstration of cardioprotection through preserved mitochondrial function is particularly significant, as mitochondrial dysfunction is increasingly recognized as a central feature in heart failure pathogenesis.
From a development perspective, these results strongly support advancing CRD-38 into clinical trials. The focus on HFpEF is strategically important, as this condition represents a significant unmet medical need with treatment options. The five-year mortality rate exceeding 75% in hospitalized patients underscores the urgent need for new therapeutic approaches.
The collaboration with the DeBakey Heart and Vascular Center adds considerable credibility to the program. As Cardiol completes its IND-enabling work, these published results provide a strong scientific foundation for upcoming regulatory submissions and potential clinical trials.
Data demonstrates improvement in cardiac function and reductions in cardiac hypertrophy, remodeling, inflammation, and cell death - key underlying mechanisms in heart failure
Toronto, Ontario--(Newsfile Corp. - February 20, 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 the publication of research in the Journal of the American College of Cardiology: Basic to Translational Science ("JACBTS"), titled "Cannabidiol Prevents Heart Failure Dysfunction and Remodeling Through Preservation of Mitochondrial Function and Calcium Handling" (www.jacc.org/doi/abs/10.1016/j.jacbts.2024.12.009). This research was conducted by scientists from Tecnológico de Monterrey who, together with researchers from the DeBakey Heart and Vascular Center in Houston, TX, are collaborating with Cardiol on the development of the Company's proprietary subcutaneous ("SubQ") formulation of cannabidiol, CRD-38, to treat heart failure with preserved ejection fraction. This common form of heart failure remains a leading cause of hospitalization worldwide and is associated with a five-year mortality that exceeds
"We are very pleased to see these comprehensive new findings from our international research collaboration culminate in this publication in one of the JACC family of journals, which are some of the most widely read, most impactful cardiovascular journals in the world," said Dr. Andrew Hamer, Cardiol Therapeutics' Chief Medical Officer and Head of Research & Development. "Heart failure progression is characterized by fibrosis, inflammation, and decreased contractile function of the myocardium, in part driven by mitochondrial dysfunction. 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, the muscle cells of the heart, and preserve mitochondrial function, the energy producing structures in cardiac cells. We look forward to incorporating this new information into our CRD-38 development program as we complete the IND-enabling work necessary to support advancing this novel drug candidate into clinical development."
These newly published data demonstrate that pharmaceutically manufactured cannabidiol, administered subcutaneously, provides cardioprotection in a pre-clinical model of heart failure by improving cardiac function and reducing cardiac hypertrophy, remodeling, inflammation, and cell death, and provides additional important rationale for the development of CRD-38 as a new approach to the treatment of heart failure.
The JACBTS publication comprises results from multiple models of heart failure:
- an in vivo model of angiotensin II-induced heart failure
- SubQ administration resulted in attenuation of cardiac fibrosis, hypertrophy, and inflammation, and also improved ejection fraction and cardiac output.
- an ex vivo analysis of heart failure ventricular myocytes from the in vivo model
- Cannabidiol preserved mitochondrial function and redox balance resulting in both cell shortening and calcium handling.
- an in vitro investigation in hypertrophic cardiac myoblast cells
- Cannabidiol provided a cardioprotective effect that may be dependent on peroxisome proliferator-activated receptor gamma ("PPAR-γ") activation, thereby decreasing mitochondrial calcium uniporter hyperactivity and preventing mitochondrial dysfunction.
Together, these results highlight the importance of mitochondrial function and the role Cardiol's small molecule drug candidate plays in protecting the heart against mitochondrial stress. The authors concluded that SubQ cannabidiol prevented inflammation and pathologic cardiac structural changes such as hypertrophy and preserved heart function. Cellular investigations suggest that this cardioprotective effect is achieved by the preservation of cardiac muscle cell shortening, sarcoplasmic reticulum calcium uptake, mitochondrial function, and redox balance which adds to the understanding of the cellular and molecular mechanisms by which CRD-38 can improve heart failure.
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 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 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 Report on Form 20-F filed with the U.S. Securities and Exchange Commission and Canadian securities regulators on April 1, 2024, 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 and are encouraged to read the Supplement, the accompanying Base Prospectus and the documents incorporated by reference therein.
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/241601
FAQ
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