Cardiol Therapeutics to Advance CardiolRx(TM) Into a Late-Stage Trial in Patients With Recurrent Pericarditis
Cardiol Therapeutics to Advance CardiolRx(TM) Into a Late-Stage Trial in Patients With Recurrent Pericarditis
MAVERIC-2 trial will evaluate the impact of CardiolRx(TM) following cessation of interleukin-1 blocker therapy (rilonacept or anakinra) and is expected to run concurrently with the Company's planned Phase III program.
MAVERIC-2试验将评估CardiolRx(TM)在白细胞介素-1阻断剂治疗(rilonacept或anakinra)停用后的影响,预计将与公司计划的III期项目同时运行。
Toronto, Ontario--(Newsfile Corp. - October 22, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, today announced plans to expand the MAVERIC clinical development program and advance CardiolRx into a late-stage clinical trial ("MAVERIC-2") to evaluate the impact of CardiolRx in recurrent pericarditis patients following cessation of interleukin-1 ("IL-1") blocker therapy. MAVERIC-2 is expected to be initiated during Q4 at major pericardial disease centres in the United States and Europe and to report results ahead of the Company's planned pivotal Phase III study in recurrent pericarditis.
安大略省多伦多--(Newsfile corp. - 2024年10月22日)--Cardiol Therapeutics Inc.(纳斯达克: CRDL)(tsx: CRDL)(“Cardiol”或“公司”),一家临床阶段的生命科学公司,专注于心脏病治疗的研究与临床开发抗炎和抗纤维化疗法,今天宣布计划扩大MAVERIC临床开发计划,并将CardiolRx推进到晚期临床试验(“MAVERIC-2”)中,以评估CardiolRx对接受白细胞介素-1(“IL-1”)阻滞剂治疗的复发性心包炎患者的影响。MAVERIC-2预计将在Q4期间在美国和欧洲的主要心包疾病中心启动,并在公司计划的复发性心包炎关键III期研究之前报告结果。
"MAVERIC-2 provides an exciting opportunity to expand the market potential for CardiolRx through the execution of a cost-effective study and potentially provides a path for an accelerated regulatory approval timeline," said David Elsley, President & CEO of Cardiol Therapeutics. "This important new study, designed in collaboration with an international panel of advisors comprised of experts in pericarditis, will also augment data from our planned Phase III MAVERIC-3 trial by exploring the potential for our lead oral drug candidate to assist the growing number of recurrent pericarditis patients who seek alternative options to chronic use of immunosuppressant biologics."
“MAVERIC-2提供了一个令人兴奋的机会,通过进行成本有效的研究,可能为CardiolRx的市场潜力扩大提供了路径,” Cardiol Therapeutics的总裁兼首席执行官David Elsley表示。"这项重要的新研究是与一组由心包炎专家组成的国际顾问团队合作设计的,还将探索我们主导口服药物候选药通过协助寻求替代免疫抑制生物制品长期使用的反复性心包炎患者的潜力,从而补充计划中的第III期MAVERIC-3试验的数据。”
MAVERIC-2 is a randomized, double-blind, placebo-controlled Phase II/III trial in approximately 110 patients. Patients with stable disease who are receiving IL-1 blocker treatment will be randomly assigned to receive either CardiolRx or placebo following cessation of the IL-1 blocker. 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 change in patient-reported pericarditis chest pain score and the inflammatory marker C-reactive protein ("CRP").
MAVERIC-2是一个大约有110名患者的随机、双盲、安慰剂对照II/III期试验。正在接受IL-1阻滞剂治疗的病情稳定的患者将被随机分配接受CardiolRx或安慰剂,随着IL-1阻滞剂治疗的停用。该试验的主要临床目标是评估CardiolRx对新发复发性心包炎发作的影响与安慰剂对比。其他感兴趣的临床终点包括心包炎复发新发作的时间、患者报告的心包炎胸痛评分以及炎症标志物C-反应蛋白(“CRP”)的变化。
IL-1 is a key pro-inflammatory cytokine in the pathophysiology of recurrent pericarditis. It is generated downstream following activation of the NLRP3 inflammasome and amplifies the autoinflammatory response characteristic of the disease. IL-1 blockers (rilonacept or anakinra) target and negate the activity of IL-1, but given their expense and immunosuppressant risks, they are generally prescribed as a third-line intervention in difficult-to-treat patients. There is a growing body of evidence indicating pericarditis recurrence rates are as high as seventy-five percent and onset is rapid following cessation of IL-1 blocker therapy. Currently, many patients who discontinue IL-1 blocker therapy and subsequently suffer a recurrence require rescue treatment with further administration of these biologics, potentially leading to IL-1 blocker dependence.
IL-1是复发性心包炎病理生理学中的关键促炎细胞因子。它在NLRP3炎性小体被激活后, 在下游-脑机生成并放大该疾病特征性的自身炎症反应。IL-1阻断剂(利洛纳塞普或阿那昔单抗)靶向并抑制IL-1的活性, 但由于昂贵和免疫抑制风险, 通常被作为难治患者的第三线干预处方。越来越多的证据表明心包炎复发率高达七十五%, 并且在停止使用IL-1阻断剂治疗后, 发作速度迅速。目前, 许多停止使用IL-1阻断剂治疗后随后出现复发的患者需要通过进一步使用这些生物制品进行抢救治疗, 可能导致对IL-1阻断剂的依赖。
"CardiolRx has been shown experimentally to inhibit assembly and activation of the NLRP3 inflammasome and the subsequent generation of IL-1, and following oral administration has led to marked reductions in pericarditis pain in patients suffering from chronic pericardial disease," said Dr. Andrew Hamer, Cardiol Therapeutics' Chief Medical Officer and Head of Research & Development. "In addition to potentially offering a more accessible and non-immunosuppressive therapy to thousands of patients who are non-responsive or intolerant to current therapies, CardiolRx may also have therapeutic potential to prevent recurrences following discontinuation of IL-1 blockers, which would address an unmet need in a growing subset of patients dependant on long-term IL-1 blocker therapy."
纳斯达克的CardiolRx已在实验中显示抑制NLRP3炎症小体的组装和激活,从而减少IL-1的生成,并在口服后可显著减轻患有慢性心包炎痛的患者的疼痛,Cardiol Therapeutics首席医务官兼研发主管安德鲁·哈默博士表示。此外,CardiolRx除了可能为数千名对当前治疗无反应或不耐受的患者提供更易获得且非免疫抑制性的疗法之外,还可能具有治疗潜力,可预防停止IL-1阻断剂后的复发,从而满足越来越多依赖长期IL-1阻断剂治疗的患者的未满足需求。
The Company previously announced positive topline data from MAvERIC-Pilot investigating CardiolRx for recurrent pericarditis which showed a substantial reduction in the primary efficacy endpoint of patient-reported pericarditis pain at the end of the 8-week treatment period ("TP"), as well as normalization of inflammation - as measured by CRP - in 80% of the patients with elevated CRP at baseline. Eighty-nine percent of patients (24/27) progressed from the TP into the now completed extension period ("EP") of the study, defined as the additional 18-week period where background therapy was weaned and patients were followed on monotherapy of CardiolRx. Full clinical data will be reported in an oral presentation November 18th, 2024, at the American Heart Association Scientific Sessions 2024 and will include freedom from pericarditis recurrence during the 18-week EP, 26-week pericarditis pain score and inflammatory marker levels, and safety and tolerability outcomes. The totality of the MAvERIC-Pilot data will support and further inform the Company's plans related to a second late-stage study called MAVERIC-3, a Phase III pivotal trial designed to assess CardiolRx for the treatment of the broader population of pericarditis patients to prevent recurrence.
公司先前宣布了MAvERIC-Pilot调查CardiolRx用于复发性心包炎的阳性主要数据,显示在8周治疗期结束时,患者报告的心包炎疼痛的主要疗效终点出现显著减少,同时80%的具有基线高CRP的患者炎症(由CRP测量)恢复正常。 89%的患者(24/27)从治疗期("TP")进入了现已完成的研究延伸期("EP"),这段期间为18周,背景治疗被减少,患者接受CardiolRx的单药治疗。全面的临床数据将于2024年11月18日在美国心脏协会2024年科学会议上以口头报告的形式报告,其中包括在延伸期的18周内免受心包炎复发、26周心包炎疼痛评分和炎症标记水平以及安全性和耐受性结果。 MAvERIC-Pilot数据的完整性将支持并对公司有关第二个后期研究MAVERIC-3的计划提供进一步信息,MAVERIC-3是一项旨在评估CardiolRx治疗更广泛心包炎患者预防复发的第III期关键试验。
Pericarditis
心包炎
Pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) frequently resulting from a viral infection. 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. 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 having experienced at least one recurrence is estimated at 38,000. Approximately 60% of patients with multiple recurrences (>1) still suffer for longer than two years, and one third are still impacted at five years. Hospitalization due to recurrent pericarditis is often associated with a 6-8-day length of stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.
心包炎是指心包(包围心脏的膜或囊)的炎症,通常是由病毒感染引起。在初次发作后,患者可能会有多次复发,治疗的主要目标是预防再发。症状包括剧烈的胸痛、呼吸急促和疲劳,导致身体活动受限、生活质量下降、急诊就诊和住院。心包积液和瘢痕明显积累可能发展成对心脏构成危及生命的压迫。2021年推出的唯一获得FDA批准的反复性心包炎治疗方案成本高昂,主要用作第三线干预。据估计,每年在美国至少经历一次复发的患者数量约为38,000人。大约60%有多次复发(>1次)的患者仍然在两年以上持续受苦,有三分之一在五年后仍受影响。由于反复性心包炎住院通常伴有6-8天的住院时间,每次费用估计在美国范围在20,000至30,000美元之间。
About Cardiol Therapeutics
关于Cardiol Therapeutics
Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is a clinical-stage life sciences company focused on the research and clinical development of 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 Therapeutics Inc.(纳斯达克:CRDL)(TSX:CRDL)是一家临床阶段的生命科学公司,专注于抗炎和抗纤维化疗法的研究和临床开发,用于治疗心脏疾病。公司的主力小分子药物候选品CardiolRx(大麻二酚)口服溶液,经过药厂生产,目前正处于临床开发阶段,用于治疗心脏疾病。人们已经认识到,大麻二酚抑制了炎症小体通路的激活,这是一种细胞内过程,已知在心肌炎、心包炎和心力衰竭中的炎症和纤维化发展过程中发挥重要作用。
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 Phase II MAvERIC-Pilot study (NCT05494788), the Phase II/III MAVERIC-2 trial, and the planned Phase III MAVERIC-3 trial. The 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已获得美国食品和药物管理局("US FDA")批准的新药申请授权,以进行评估CardiolRx在影响心脏的两种疾病中的功效和安全性的临床研究:反复性心包炎和急性心肌炎。MAVERIC计划中的反复性心包炎,是一种与症状包括令人难以忍受的胸痛、气促和疲劳以及导致身体功能受限、生活质量降低、急诊科就诊和住院相关的心包膜炎症性疾病,包括II期MAvERIC-Pilot研究(NCT05494788)、II/III期MAVERIC-2试验和计划中的III期MAVERIC-3试验。ARCHER试验(NCT05180240)是急性心肌炎的II期研究,是导致年轻成年人急性和病势凶险性心力衰竭以及35岁以下人群猝死的主要原因。美国FDA已授予CardiolRx治疗心包炎(包括反复性心包炎)的孤儿药物认定。
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.
Trevor Burns,投资者关系,+1-289-910-0855 ,trevor.burns@cardiolrx.com
For more information about Cardiol Therapeutics, please visit cardiolrx.com.
请访问cardiolrx.com获取有关Cardiol Therapeutics的更多信息。
Cautionary Statement Regarding Forward-Looking Information:
关于前瞻性信息的警示性声明:
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". Forward looking information contained herein may include, but is not limited to statements regarding the Company's plans to expand the MAVERIC clinical development program and advance CardiolRx into a late-stage clinical trial called MAVERIC-2, the Company's expectation to initiate the MAVERIC-2 study during the fourth quarter of 2024 at major pericardial disease centres in the United States and Europe and report results ahead of the Company's planned pivotal Phase III study in recurrent pericarditis, the Company's plans to conduct its Phase III study in recurrent pericarditis concurrently with MAVERIC-2, the Company's intention to report full clinical data from the MAvERIC-Pilot study in an oral presentation at the American Heart Association Scientific Sessions 2024, the Company's expectation that the full clinical data from the MAvERIC-Pilot study presented will include freedom from pericarditis recurrence during the 18-week EP, 26-week pericarditis pain score and inflammatory marker levels and safety and tolerability outcomes, the Company's belief that the MAvERIC-Pilot study data will support and further inform the Company's plans related to a second late-stage study called MAVERIC-3 which the Company intends to be a Phase III pivotal trial designed to assess CardiolRx for the treatment of the broader population of pericarditis patients to prevent recurrence, 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, and the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure. 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.
本新闻发布包含适用证券法律意义下的“前瞻性信息”。除历史事实陈述外,凡涉及或预期 Cardiol认为可能在未来发生的活动、事件或发展的所有陈述均属于“前瞻性信息”。此处包含的前瞻性信息可能包括但不限于有关公司计划扩大 MAVERIC 临床开发计划并将 CardiolRx 推进至被称为 MAVERIC-2 的晚期临床试验,公司期望于2024年第四季度在美国和欧洲主要心包疾病中心启动 MAVERIC-2 研究并在公司计划的复发性心包炎关键III期试验之前报告结果,公司计划同时进行复发性心包炎关键III期试验和 MAVERIC-2,公司打算在2024年美国心脏协会科学会议上以口头报告的形式发布 MAvERIC-Pilot 研究的完整临床数据,公司预期 MAvERIC-Pilot 研究呈现的完整临床数据将包括18周内心包炎复发的自由,26周内心包炎疼痛分数和炎症标记水平以及安全性和耐受性结果,公司相信 MAvERIC-Pilot 研究数据将支持并进一步指导公司与第二项晚期研究 MAVERIC-3 有关的计划,该公司拟将该研究设为旨在评估 CardiolRx 用于治疗更广泛心包炎患者防止复发的关键III期试验,公司专注于开发用于治疗心脏疾病的抗炎和抗纤维化疗法,公司产品候选药物的分子靶点和作用机制,公司拟开展的临床研究和试验活动以及与该类活动有关的时间安排,包括公司完成复发性心包炎关键III期试验的计划以及推进 CRD-38 的发展,这是一种旨在用于心衰的新型皮下大麻二酚制剂的计划。此处包含的前瞻性信息反映了 Cardiol 根据其当前取得的信息的当前期望或信念,并基于某些假设,也受各种已知和未知的风险、不确定性以及可能导致实际事件或结果与前瞻性信息所揭示的任何未来结果、表现或成就大相径庭的其他因素影响,并不(也不应被视为)对未来表现的保证。这些风险、不确定性和其他因素包括公司于2024年4月1日向美国证券交易委员会和加拿大证券监管机构提交的年度20-F表中提及的风险与不确定性,以及与产品商业化和临床研究有关的风险与不确定性。这些假设、风险、不确定性和其他因素应慎重考虑,投资者不应过分依赖前瞻性信息,此类信息可能不适用于其他用途。任何前瞻性信息仅反映本新闻发布的日期,除非适用证券法律要求,Cardiol否认任何故意或义务更新或修订此类前瞻性信息,无论是因新信息、未来事件或结果,还是其他缘故。投资者被告诫不要依赖这些前瞻性陈述,鼓励阅读配套文件、附表以及其引用的文件。
For further information, please contact:
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
如需更多信息,请联系:
投资者关系 Trevor Burns +1-289-910-0855 trevor.burns@cardiolrx.com
投资者关系 Trevor Burns +1-289-910-0855 trevor.burns@cardiolrx.com