Cardiol Therapeutics將在患有複發性心包炎的患者中推進CardiolRx™進入晚期試驗。
與複發性心包炎患者一起。

MAVERIC-2 試驗將評估 CardiolRx™ 在停藥後的影響

干擾素-1阻斷劑療法（利洛那塞普或阿那曲星）預期

與公司計劃的第三階段項目同時進行

tsx - 2024年10月22日多倫多 - Cardiol Therapeutics Inc.（Cardiol已經獲得美國FDA的新藥申請授權，以評估CardiolRx在兩種影響心臟的疾病治療中的療效和安全性：（i）複發性心包炎（MAvERIC-Pilot研究；NCT05494788），心包囊的炎性疾病，伴隨有令人痛苦的胸痛、呼吸急促和疲勞的症狀，導致身體的限制、生活質量降低、急診就醫和住院入院；（ii）急性心肌炎的多國、隨機、雙盲、安慰劑對照試驗（ARCHER試驗；NCT05180240），是年輕成年人急性和暴發性心力衰竭的重要原因，也是35歲以下人群猝死的主要原因。美國FDA已授予CardiolRx孤兒藥物指定，用於治療包括複發性心包炎在內的心包炎。) (Cardiol還開發了CRD-38，一種新型皮下給藥的藥物製劑，旨在治療心衰——在發達國家是導致死亡和住院的主要原因，與美國的醫療保健費用超過300億美元相關。) ("Cardiol"或"公司一家臨床階段的生命科學公司，專注於心髒病治療的抗炎和抗纖維化療法的研究和臨床開發。今天宣佈計劃擴大MAVERIC臨床開發項目，並將CardiolRx™推進到一個後期臨床試驗（"MAVERIC-2"），以評估CardiolRx™在停止白細胞介素-1（"IL-1"）阻斷劑治療後複發性心包炎患者中的影響。MAVERIC-2預計將在Q4在美國和歐洲主要心包疾病中心啓動，並在公司計劃的複發性心包炎關鍵性第三階段研究之前報告結果。

「MAVERIC-2提供了一個令人興奮的機會，通過進行成本有效的研究，可能爲CardiolRx的市場潛力擴大提供了路徑，」 Cardiol Therapeutics的總裁兼首席執行官David Elsley表示。"這項重要的新研究是與一組由心包炎專家組成的國際顧問團隊合作設計的，還將探索我們主導口服藥物候選藥通過協助尋求替代免疫抑制生物製品長期使用的反覆性心包炎患者的潛力，從而補充計劃中的第III期MAVERIC-3試驗的數據。”

MAVERIC-2是一個約有110名患者的隨機、雙盲、安慰劑對照的II/III期試驗。處於穩定病情的接受IL-1阻滯劑治療的患者將被隨機分配到在停止IL-1阻滯劑後接受CardiolRx™或安慰劑。試驗的主要臨床目標將是評估CardiolRx™與安慰劑對減少複發性心包炎新發作的影響。其他感興趣的臨床終點包括心包炎復發的時間、病人報告心包炎胸痛評分的變化以及炎症標誌物C-反應蛋白（"CRP"）。

IL-1是複發性心包炎病理生理學中的關鍵促炎細胞因子。它在NLRP3炎性小體被激活後, 在下游-腦機生成並放大該疾病特徵性的自身炎症反應。IL-1阻斷劑（利洛納塞普或阿那昔單抗）靶向並抑制IL-1的活性, 但由於昂貴和免疫抑制風險, 通常被作爲難治患者的第三線干預處方。越來越多的證據表明心包炎複發率高達七十五％, 並且在停止使用IL-1阻斷劑治療後, 發作速度迅速。目前, 許多停止使用IL-1阻斷劑治療後隨後出現復發的患者需要通過進一步使用這些生物製品進行搶救治療, 可能導致對IL-1阻斷劑的依賴。

「CardiolRx™已在實驗中顯示可以抑制NLRP3炎症小體的組裝和激活，進而降低IL-1的生成，口服後可顯著減輕患有慢性心包炎的患者的疼痛，」 Cardiol Therapeutics首席醫療官兼研發負責人安德魯·哈默博士說道。"除了可能爲成千上萬不響應或不耐受當前療法的患者提供更易獲得且非免疫抑制性的治療方法外，CardiolRx™還可能具有治療潛力，可以預防在停用IL-1阻滯劑後出現再發，從而滿足長期依賴IL-1阻滯劑治療的不斷增長的患者群體的未滿足需求。"

公司先前宣佈MAvERIC-Pilot從事對複發性心包炎的CardiolRx™的臨床試驗獲得了積極的上線數據，顯示在8周治療期末（「TP」）患者報告的心包炎疼痛的主要療效終點有顯著降低，以及在基線時CRP升高的80%患者的炎症水平的正常化。其中89%的患者（24/27）從TP進展到了該研究現已完成的延長期（「EP」），該期間定義爲背景治療已經緩解，患者轉爲單獨使用CardiolRx™進行治療的額外18周。全面的臨床數據將於11月18日的口頭報告中公佈。^th，2024年，在美國心臟協會2024年科學會議上將報告完整的臨床數據，包括18周EP期間免於心包炎復發、26周心包炎疼痛評分和炎症標誌物水平，以及安全性和耐受性結果。MAvERIC-Pilot數據的整體將支持和進一步指導公司與第二個晚期研究MAVERIC-3相關的計劃，MAVERIC-3是一個設計用於評估CardiolRx™治療更廣泛心包炎患者以預防復發的III期關鍵性試驗。

心包炎

心包炎是指心包（包圍心臟的膜或囊）的炎症，通常是由病毒感染引起。在初次發作後，患者可能會有多次復發，治療的主要目標是預防再發。症狀包括劇烈的胸痛、呼吸急促和疲勞，導致身體活動受限、生活質量下降、急診就診和住院。心包積液和瘢痕明顯積累可能發展成對心臟構成危及生命的壓迫。2021年推出的唯一獲得FDA批准的反覆性心包炎治療方案成本高昂，主要用作第三線干預。據估計，每年在美國至少經歷一次復發的患者數量約爲38,000人。大約60%有多次復發（>1次）的患者仍然在兩年以上持續受苦，有三分之一在五年後仍受影響。由於反覆性心包炎住院通常伴有6-8天的住院時間，每次費用估計在美國範圍在20,000至30,000美元之間。

關於心臟療法

Cardiol Therapeutics Inc.（NASDAQ: CRDL，TSX: CRDL）是一家臨床生命科學公司，專注於心髒病的抗炎和抗纖維化療法的研究和臨床開發。該公司的主導小分子藥物候選者CardiolRx（大麻二酚）口服溶液，通過製藥生產並處於治療心臟病的臨床開發中。人們認識到，大麻二酚抑制炎症小體通路的激活，這是細胞內過程的一部分，已知在心肌炎、心包炎和心力衰竭伴隨的炎症和纖維化的發展和進展中發揮重要作用。Cardiol已經獲得美國FDA的新藥申請授權，以評估CardiolRx在兩種影響心臟的疾病治療中的療效和安全性：（i）複發性心包炎（MAvERIC-Pilot研究；NCT05494788），心包囊的炎性疾病，伴隨有令人痛苦的胸痛、呼吸急促和疲勞的症狀，導致身體的限制、生活質量降低、急診就醫和住院入院；（ii）急性心肌炎的多國、隨機、雙盲、安慰劑對照試驗（ARCHER試驗；NCT05180240），是年輕成年人急性和暴發性心力衰竭的重要原因，也是35歲以下人群猝死的主要原因。美國FDA已授予CardiolRx孤兒藥物指定，用於治療包括複發性心包炎在內的心包炎。) (Cardiol還開發了CRD-38，一種新型皮下給藥的藥物製劑，旨在治療心衰——在發達國家是導致死亡和住院的主要原因，與美國的醫療保健費用超過300億美元相關。）是一家臨床階段的生命科學公司，專注於抗炎和抗纖維化治療心臟病的研究和臨床開發。該公司的首席小分子藥物候選藥CardiolRx™（大麻二酚）口服溶液，經過藥用製造並處於臨床開發階段，用於治療心臟病。人們認識到，大麻二酚抑制促炎體途徑的激活，這是一種已知在心肌炎、心包炎和心力衰竭的炎症和纖維化發展和進展中發揮重要作用的細胞內過程。

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 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.

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 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.

For further information, please contact:

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

trevor.burns@cardiolrx.com