卡迪奥治疗公司宣布2024年底运营更新-动脉网

Cardiol Therapeutics Announces Year-End 2024 Update on Operations

INN 等信源发布 2025-04-02 11:12

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Investing News Network

投资新闻网

April 01, 2025

2025年4月1日

Reported positive data from the Phase II MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis; results support advancing to the Phase III MAVERIC trial

MAvERIC-试点研究的II期临床试验报告了积极数据，该研究调查了对症状性复发性心包炎患者使用CardiolRx™的效果；结果支持推进到III期MAVERIC试验。

Completed patient enrollment in the Phase II ARCHER trial evaluating CardiolRx™ in patients

已完成在评估CardiolRx™的二期ARCHER试验中的患者入组

with acute myocarditis, with topline data expected in Q2 2025

患有急性心肌炎，预计2025年第二季度会有顶线数据

CardiolRx™ granted U.S. FDA Orphan Drug Designation for the treatment of pericarditis,

CardiolRx™ 获得美国 FDA 授予的治疗心包炎的孤儿药资格，

which includes recurrent pericarditis

其中包括复发性心包炎

Cash and cash equivalents of $30.6 million as of December 31, 2024,

截至2024年12月31日，现金及现金等价物为3060万美元，

to fund operations into Q3 2026

为2026年第三季度的运营提供资金

Cardiol Therapeutics Inc.

卡迪奥治疗公司

(

NASDAQ

纳斯达克

: CRDL) (

TSX

: CRDL)

：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 its year-end 2024 update on operations following the filing of its audited Financial Statements and Management's Discussion and Analysis for the year ended December 31, 2024.

（“Cardiol”或“公司”），一家专注于开发抗炎和抗纤维化疗法用于治疗心脏病的临床阶段生命科学公司，于今天在提交截至2024年12月31日的年度审计财务报表及管理层讨论与分析后，公布了其2024年终运营更新。

Both are available under the Company's profile on EDGAR at .

两者均可在EDGAR上的公司简介中找到。

www.sec.gov

, on SEDAR+ at

，在SEDAR+上

sedarplus.ca

and on the Company's website at

并在公司的网站上

cardiolrx.com

。

Cardiol Therapeutics

心脏病治疗中心

achieved significant milestones during 2024 which have supported advancing CardiolRx into the Phase III MAVERIC trial in recurrent pericarditis - a debilitating heart disease that remains underserved by available medicine,' said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics.

Cardiol Therapeutics总裁兼首席执行官David Elsley表示：“我们在2024年取得了重要的里程碑，这些成就支持将CardiolRx推进到针对复发性心包炎的III期MAVERIC试验。复发性心包炎是一种令人衰弱的心脏疾病，现有的药物仍然无法充分满足其治疗需求。”

'We are very encouraged by the compelling Phase II data presented at the American Heart Association Scientific Sessions 2024, demonstrating that CardiolRx™ reduced pericarditis pain, inflammation, and episodes of recurrence in patients presenting with a high degree of disease burden. We were also pleased that our Phase II ARCHER trial surpassed expectations by completing patient enrollment ahead of schedule, positioning the Company to report topline data in Q2.

“我们在2024年美国心脏协会科学会议上展示的令人信服的二期数据感到非常鼓舞，数据显示CardiolRx™减轻了伴有高度疾病负担患者的心包炎疼痛、炎症和复发次数。我们也很高兴二期ARCHER试验超越预期，提前完成了患者入组，使公司有望在第二季度报告初步数据。

With operations funded into the second half of 2026, we remain committed to advancing our late-stage clinical development pipeline in pericarditis and myocarditis, and to progressing the IND-enabling program to support the clinical development of CRD-38 for heart failure. We would like to express our sincere gratitude to our clinical collaborators and patients whose support has enabled our progress.'.

在运营资金支持到2026年下半年的情况下，我们仍致力于推进针对心包炎和心肌炎的后期临床开发管线，并推动支持CRD-38治疗心力衰竭临床开发的IND启用计划。我们要向我们的临床合作者和患者表示衷心感谢，他们的支持使我们的进展成为可能。

Key Highlights:

关键亮点：

MAVERIC Program in Recurrent Pericarditis

MAVERIC计划在复发性心包炎中的应用

In February 2024, CardiolRx™ was granted Orphan Drug Designation by the United States Food and Drug Administration for the treatment of pericarditis, which includes recurrent pericarditis. Pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) frequently resulting from a viral infection.

2024年2月，CardiolRx™ 被美国食品药品监督管理局授予用于治疗心包炎（包括复发性心包炎）的孤儿药资格。心包炎是指心包（围绕心脏的膜或囊）的炎症，通常由病毒感染引起。

Following that initial episode patients may have multiple recurrences, 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.

在初次发作之后，患者可能会有多次复发，治疗的主要目标是预防复发。症状包括严重的胸痛、呼吸急促和疲劳，导致身体活动受限、生活质量下降、急诊就诊以及住院治疗。

Pericarditis affects approximately 160,000 individuals in the United States annually, with 38,000 suffering from recurrent episodes..

心包炎每年在美国影响大约 160,000 人，其中 38,000 人患有复发性发作。

In June 2024, Cardiol reported topline 8-week clinical data from its Phase II MAvERIC-Pilot study demonstrating a marked reduction in pericarditis pain, and in November 2024, the Company reported full results from the study concurrent with the American Heart Association Scientific Sessions 2024 ('AHA 2024').

2024年6月，Cardiol公司报告了其II期MAvERIC-Pilot研究的8周初步临床数据，显示心包炎疼痛显著减轻，并于2024年11月，在2024年美国心脏协会科学会议（AHA 2024）期间公布了该研究的完整结果。

The data were included in an oral presentation as part of the Laennec Clinician-Educator Award & Lecture at the AHA 2024. Dr. S. Allen Luis, Co-Director of the Pericardial Diseases Clinic and Associate Professor of Medicine in the Department of Cardiovascular Medicine at the Mayo Clinic, presented on behalf of the MAvERIC-Pilot investigators.

数据被纳入作为AHA 2024年Laennec临床教育家奖及讲座的一部分的口头报告中。梅奥诊所心包疾病诊所联合主任、心血管内科医学副教授S. Allen Luis博士代表MAvERIC-Pilot研究者进行了报告。

MAvERIC-Pilot enrolled 27 participants with symptomatic recurrent pericarditis at eight clinical sites across the United States. The results showed that patients, despite the severity of their disease, experienced marked, rapid, and durable reductions in both pericarditis pain and inflammation and importantly these reductions were maintained throughout the 6-month study.

MAvERIC-Pilot 在美国八个临床站点招募了 27 名有症状的复发性心包炎患者。结果显示，尽管患者的病情严重，但他们在心包炎疼痛和炎症方面均经历了显著、快速且持久的减轻，重要的是，这些改善在为期 6 个月的研究中一直得以维持。

In addition, the results demonstrated a notable reduction in pericarditis episodes per year. Treatment with CardiolRx™ was shown to be safe and well tolerated..

此外，结果表明每年心包炎发作次数显著减少。CardiolRx™ 治疗显示安全且耐受性良好。

Based on the compelling results from MAvERIC-Pilot, in October 2024, Cardiol announced advancing to the Phase III MAVERIC trial, a randomized, double-blind, placebo-controlled trial expected to enroll 110 patients at high risk for disease recurrence at approximately 20 clinical sites in the United States and Europe.

基于MAvERIC-Pilot令人信服的结果，Cardiol公司在2024年10月宣布将推进到III期MAVERIC试验，这是一项随机、双盲、安慰剂对照的试验，预计将在美国和欧洲的大约20个临床站点招募110名疾病复发高风险患者。

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. Other clinical endpoints of interest include time to a new episode of pericarditis recurrence, and changes in patient-reported pericarditis chest pain score and the inflammatory marker C-reactive protein..

该试验的主要临床目标是评估CardiolRx™与安慰剂相比对预防复发性心包炎新发作的影响。其他感兴趣的临床终点包括心包炎复发新发作的时间，以及患者报告的心包炎胸痛评分和炎症标志物C反应蛋白的变化。

ARCHER Trial in Acute Myocarditis

急性心肌炎的ARCHER试验

In May 2024, the ARCHER trial was the subject of an oral presentation at the World Congress on Acute Heart Failure 2024 in Lisbon, Portugal, at the annual congress of the Heart Failure Association of the European Society of Cardiology ('ESC'). The trial design and rationale were presented by Univ.-Prof.

2024年5月，ARCHER试验在葡萄牙里斯本举行的2024年急性心力衰竭世界大会和欧洲心脏病学会（ESC）心力衰竭协会的年度大会上进行了口头报告。试验设计和理由由大学教授展示。

Dr. med. Carsten Tschöpe from the Berlin Institute of Health - Charité, on behalf of the ARCHER Study Group, an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence. Concurrent with the presentation the journal ESC Heart Failure, which is dedicated to advancing knowledge about heart failure worldwide, accepted the manuscript describing the rationale and design of the ARCHER trial and it was published in June 2024..

柏林健康研究所 - 慈善医院的卡斯滕·切佩医学博士代表ARCHER研究组，该研究组是一个独立的指导委员会，由来自国际卓越中心的心力衰竭和心肌炎领域的杰出思想领袖组成。在演讲的同时，致力于推动全球心力衰竭知识发展的《ESC心力衰竭》期刊接受了描述ARCHER试验原理和设计的手稿，并于2024年6月发表。

In September 2024, Cardiol announced the completion of patient enrollment in ARCHER with topline results expected to be reported in Q2 2025. ARCHER enrolled over 100 patients at 34 clinical sites in the United States, Canada, France, Brazil, and Israel. The two primary outcome measures of the trial consist of myocardial magnetic resonance imaging parameters: global longitudinal strain and extra-cellular volume, which measure heart dysfunction and edema/fibrosis, respectively.

2024年9月，Cardiol宣布完成ARCHER的患者入组，预计将在2025年第二季度报告初步结果。ARCHER在美国、加拿大、法国、巴西和以色列的34个临床试验点招募了100多名患者。该试验的两个主要结局指标包括心肌磁共振成像参数：整体纵向应变和细胞外体积，分别用于测量心脏功能障碍和水肿/纤维化。

Each of these parameters has been shown to associate with adverse outcomes and predict long-term prognosis in patients with acute myocarditis. There are no FDA-approved therapies for myocarditis, and it remains 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..

这些参数均表明与不良结果相关，并能预测急性心肌炎患者的长期预后。目前尚无FDA批准的治疗心肌炎的方法，但它仍然是导致急性心力衰竭和爆发性心力衰竭的重要原因，也是35岁以下人群猝死的主要原因。

CRD-38 Pre-Clinical Development

CRD-38 临床前开发

In February 2025, Cardiol announced the publication of research in the

2025年2月，Cardiol宣布了研究的发表在

Journal of the American College of Cardiology: Basic to Translational Science

美国心脏病学会杂志：从基础到转化科学

, titled 'Cannabidiol Prevents Heart Failure Dysfunction and Remodeling Through Preservation of Mitochondrial Function and Calcium Handling' (

，标题为《大麻二酚通过保护线粒体功能和钙处理预防心力衰竭功能障碍和重构》（

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 formulation of cannabidiol, CRD-38, to treat heart failure with preserved ejection fraction.

）。这项研究由特克诺洛吉科德蒙特雷的科学家进行，他们与德贝基休斯顿心脏和血管中心的研究人员一起，正与Cardiol合作开发该公司专有的大麻二酚皮下注射配方CRD-38，用于治疗射血分数保留的心力衰竭。

This common form of heart failure remains a leading cause of hospitalization worldwide and is associated with a five-year mortality that exceeds 75% in hospitalized patients..

这种常见的心力衰竭仍然是全球住院治疗的主要原因之一，并且在住院患者中，其五年死亡率超过75%。

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..

这些新发布的数据表明，通过皮下注射给予药用制造的大麻二酚，在心力衰竭的临床前模型中，通过改善心脏功能、减少心脏肥大、重塑、炎症和细胞死亡，提供了心脏保护作用，并为开发CRD-38作为治疗心力衰竭的新方法提供了更多重要的理论依据。

Capital Management

资本管理

In October 2024, Cardiol successfully closed a public offering for gross proceeds of US$15,525,000. Cash and cash equivalents were $30.6 million as of December 31, 2024. Based on current projections, the Company believes current cash will fund operations and capital requirements, associated with achieving corporate milestones into Q3 2026..

2024年10月，Cardiol成功完成了一次公开募股，总收益为15,525,000美元。截至2024年12月31日，公司的现金及现金等价物为3060万美元。根据当前预测，公司认为现有现金将足以支持运营和资本需求，并实现企业目标直至2026年第三季度。

Outlook

前景

During the next 12 - 18 months, the Company expects to achieve a number of significant corporate milestones, including:

在接下来的12到18个月内，公司预计将实现若干重大的企业里程碑，包括：

Enrollment of first patient in the Phase III MAVERIC clinical trial evaluating CardiolRx™ in pericarditis patients at high risk for disease recurrence. MAVERIC has been designed in collaboration with experts in pericarditis from around the world and, subject to study outcomes, is expected to support a New Drug Application with the FDA.

MAVERIC III期临床试验中首位患者的入组，该试验旨在评估CardiolRx™在高复发风险的心包炎患者中的效果。MAVERIC已与全球心包炎领域的专家合作设计，根据研究结果，有望支持向FDA提交新药申请。

The Company anticipates achieving 50% of patient enrollment during H2 2025 and completing patient enrollment in H1 2026..

公司预计在2025年下半年完成50%的患者招募，并在2026年上半年完成全部患者招募。

Report topline date from the Phase II ARCHER trial investigating the impact of CardiolRx™ on myocardial recovery in patients with acute myocarditis. ARCHER results are expected to further inform the cardiology community concerning the anti-fibrotic and anti-inflammatory effects of CardiolRx™.

报告来自第二阶段ARCHER试验的头条日期，该试验调查了CardiolRx™对急性心肌炎患者心肌恢复的影响。ARCHER的结果预计将进一步向心脏病学界提供有关CardiolRx™抗纤维化和抗炎作用的信息。

Based on recent data published in the

基于最近发布的数据

Journal of the American College of Cardiology

美国心脏病学会杂志

that provides new insights concerning the ability of CRD-38 to protect cardiomyocytes (the muscle cells of the heart) and preserve mitochondrial function (the energy-producing structures in cardiac cells), the Company will advance the IND-enabling work necessary to support the clinical development of CRD38 for heart failure..

这为CRD-38保护心肌细胞（心脏的肌肉细胞）和维持线粒体功能（心肌细胞中产生能量的结构）的能力提供了新的见解，该公司将推进支持CRD38用于心力衰竭临床开发所需的IND相关工作。

About Cardiol Therapeutics

关于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.

Cardiol Therapeutics Inc.（纳斯达克股票代码：CRDL）（多伦多证券交易所股票代码：CRDL）是一家临床阶段的生命科学公司，专注于开发用于治疗心脏病的抗炎和抗纤维化疗法。该公司主要的小分子候选药物CardiolRx™（大麻二酚）口服溶液通过制药工艺生产，目前正处于临床开发阶段，用于治疗心脏病。

It is recognized that cannabidiol modulates 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..

研究表明，大麻二酚能够调节炎症小体通路的激活，这一细胞内过程在心肌炎、心包炎和心力衰竭相关的炎症和纤维化的发展及进展中起重要作用。

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).

Cardiol 已获得美国食品药品监督管理局（US FDA）的新药临床试验申请批准，将开展临床研究以评估 CardiolRx™ 在两种心脏疾病中的疗效和安全性：复发性心包炎和急性心肌炎。MAVERIC 计划针对复发性心包炎，这是一种心包的炎症性疾病，伴随的症状包括严重的胸痛、呼吸急促和疲劳，并导致身体活动受限、生活质量下降、急诊就诊和住院。该计划包括已完成的 II 期 MAvERIC-Pilot 研究（NCT05494788）以及正在进行的 III 期 MAVERIC 试验（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..

正在进行的ARCHER试验（NCT05180240）是一项针对急性心肌炎的II期研究，急性心肌炎是导致年轻人急性及暴发性心力衰竭的重要原因，也是35岁以下人群猝死的主要原因之一。美国FDA已授予CardiolRx™治疗心包炎（包括复发性心包炎）的孤儿药资格。

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.

Cardiol 还在开发 CRD-38，这是一种新型的皮下注射药物配方，用于治疗心力衰竭——这是发达国家死亡和住院的主要原因之一，美国与此相关的医疗费用每年超过 300 亿美元。

For more information about Cardiol Therapeutics, please visit

有关Cardiol Therapeutics的更多信息，请访问

cardiolrx.com

。

Cautionary statement regarding forward-looking information:

关于前瞻性信息的警示声明：

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'.

本新闻稿包含适用证券法意义上的“前瞻性信息”。所有陈述，除历史事实陈述外，凡涉及Cardiol认为、预期或预期将会、可能、能够或也许在未来发生的活动、事件或发展的，均为“前瞻性信息”。

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 Company's expectation that operations will be funded into Q3 2026, the Company's expectation of reporting ARCHER topline data in Q2 2025 and the Company's expectation that it will achieve significant corporate milestones during the next 12 - 18 months.

本文包含的前瞻性信息可能包括但不限于以下声明：公司专注于开发用于治疗心脏病的抗炎和抗纤维化疗法、公司候选产品的分子靶点及其作用机制、公司计划的临床研究和试验活动及相关时间表，包括公司计划完成CardiolRx在复发性心包炎中的III期研究、公司计划推进CRD-38（一种用于心力衰竭的新型皮下注射大麻二酚制剂）的开发、公司预计运营资金将支持到2026年第三季度、公司预计将于2025年第二季度报告ARCHER的顶线数据，以及公司预计在未来12至18个月内将实现重要的企业里程碑。

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.

本文所含前瞻性信息反映了Cardiol基于当前可获得的信息对其的当前预期或信念，该信息基于某些假设，并受到各种已知和未知风险、不确定性及其他因素的影响，这些因素可能导致实际事件或结果与前瞻性信息所表达或暗示的任何未来结果、业绩或成就存在重大差异，且不构成（也不应被视为）对未来业绩的保证。

These ris.

这些风险。

For further information, please contact:

如需更多信息，请联系：

Trevor Burns, Investor Relations +1-289-910-0855

特雷弗·伯恩斯，投资者关系 +1-289-910-0855

trevor.burns@cardiolrx.com

Source

源

Click here to connect with Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) to receive an Investor Presentation

点击这里与Cardiol Therapeutics Inc.（纳斯达克代码：CRDL）（多伦多证券交易所代码：CRDL）联系，获取投资者报告。