Patients with recurrent pericarditis who are refractory or intolerant to current therapeutic management options or who require long-term administration of corticosteroids to control their disease are particularly challenging to manage. The pathogenesis of pericarditis involves the activation of the inflammasome. CardiolRxTM (a pure cannabidiol [CBD] solution) is known to have anti-inflammatory properties, including modulation of inflammasome signaling. This pilot study is to assess the tolerance and safety of CardiolRxTM during the resolution of pericarditis symptoms, assess improvement in objective measures of disease, and during the extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids while taking CardiolRxTM.

开始日期2022-11-30

申办/合作机构

Cardiol Therapeutics, Inc.

NCT05180240 / Recruiting临床2期

Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis. A Double-blind, Placebo-controlled Trial

Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis will be screened and, if eligible, randomized within 10 days of the diagnostic CMR to CardiolRx or placebo.
CardiolRx is pharmaceutically produced Cannabidiol and is free of tetrahydrocannabinol (THC<5 ppm). The treatment period is 12 weeks; a last follow-up visit is scheduled one week after the last treatment, 13 weeks after randomization. Study assessments include Cardiac Magnetic Resonance imaging (CMR), ECG monitoring, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as physical exams and laboratory tests.
The primary and secondary outcome parameters are measured by CMR. Additional outcomes include clinical endpoints and changes in inflammatory and biomarkers.

开始日期2022-06-22

申办/合作机构

Cardiol Therapeutics, Inc.

NCT04899050 / Completed临床4期IIT

Safety and Efficacy of CBD (Epidiolex) in Idiopathic Generalized Epilepsy With Typical Absence Seizures

This is a Pilot study, open-label study consisting of a screening period of up to 4 weeks, a 4-week dose-titration treatment period to dose of up to 20 mg/kg/day BID of CBD (Epidiolex), and a 30 day safety follow-up period following the last dose of study medication.

开始日期2021-07-30

申办/合作机构

University of South Florida

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2024-06-13

·BioSpace

Cardiol Therapeutics Announces Positive Topline Data from its Phase II MAvERIC-Pilot Study Investigating CardiolRx(TM) for Recurrent Pericarditis

Administration of CardiolRx™ led to a marked reduction in the primary efficacy endpoint of pericarditis pain CardiolRx™ also shown to reduce inflammation in patients with elevated CRP 89% of patients have continued into the extension phase of the study Toronto, Ontario--(News - June 13, 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 reported 8-week clinical data from its Phase II open-label MAvERIC-Pilot study investigating the impact of CardiolRx™ administered to patients with symptomatic recurrent pericarditis. The data 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 C-reactive protein ("CRP") - in 80% of patients with elevated CRP at baseline. "We are delighted to share the primary endpoint data from the MAvERIC-Pilot study, demonstrating that oral administration of our small molecule CardiolRx™ led to marked reductions in pericarditis pain and inflammation, which were remarkably comparable in magnitude to the changes reported following immunosuppressive biologic therapy commonly used in third-line treatment of recurrent pericarditis," said David Elsley, Cardiol Therapeutics' President and Chief Executive Officer. "Based on the clinically meaningful impact of CardiolRx™ on the key symptom of this debilitating disease, we now anticipate that the totality of the MAvERIC-Pilot data will support advancing to a Phase III trial of CardiolRx™ designed to meet our objective of providing a more accessible and non-immunosuppressive therapy option for thousands of pericarditis patients." MAvERIC-Pilot enrolled 27 patients diagnosed with symptomatic recurrent pericarditis. Each patient had a high disease burden as reflected in the mean baseline pericarditis pain score of 5.8 out of 10, and by the number of previous episodes of pericarditis: 9 patients (33%) with 2 previous episodes; 9 (33%) with 3; 4 (15%) with 4; and 5 (19%) with >4. Summary of topline findings include: Primary endpoint of patient-reported pericardial pain on an 11-point numerical rating scale ("NRS") showed a mean reduction of 3.7, from 5.8 at baseline (range of 4 to 10) to 2.1 (range of 0 to 6) at 8 weeks. NRS is a validated instrument used to assess patient-reported pericarditis pain. Zero represents 'no pain at all', whereas the upper limit of 10 represents 'the worst pain ever possible'. Eight of the ten patients (80%) with a baseline CRP ≥1mg/dL had a normalization of CRP (≤0.5 mg/dL) at 8 weeks. The mean CRP decreased from 5.7 mg/dL at baseline to 0.3 mg/dL at 8 weeks. CRP is a commonly used clinical marker of inflammation, and in combination with the NRS score, is used by clinicians to assess clinical response and determine a recurrence. Eighty-nine percent of patients (24/27) have progressed from the TP into the extension period ("EP") of the study, defined as the additional 18-week period of CardiolRx™ treatment that follows the TP. CardiolRx™ was shown to be safe and generally well-tolerated. MAvERIC-Pilot Study Design The ongoing MAvERIC-Pilot study is evaluating CardiolRx™ in 27 adult participants (≥18 years) with symptomatic recurrent pericarditis (≥2 recurrences), with or without a raised CRP, at eight clinical sites across the United States. The study Chairman is Allan L. Klein, MD, Director of the Center of Pericardial Diseases and Professor of Medicine, Heart and Vascular Institute, at the Cleveland Clinic. The study design consists of an 8-week TP followed by an 18-week EP. Patients with pericarditis chest pain with an NRS pain score ≥4 together with either an elevated CRP (≥1mg/dL) or evidence of pericardial inflammation assessed by cardiac imaging have been enrolled. CardiolRx™ is added to stable doses of baseline therapy for recurrent pericarditis (non-steroidal anti-inflammatory drugs, colchicine, or corticosteroids, in any combination). In the first 10 days of the TP, CardiolRx™ is up-titrated to 10 mg/kg twice daily, or the maximum tolerated dose. Throughout the TP, patients continue receiving baseline therapy for recurrent pericarditis but are weaned off this during the EP to assess pericarditis recurrence. The primary efficacy endpoint is the change, from baseline to 8 weeks, in patient-reported pericarditis pain using the NRS. Secondary endpoints include NRS pain score at 26 weeks, and freedom from pericarditis recurrence during the EP. Secondary CRP endpoints of interest include change from baseline to 26 weeks, and for patients with CRP ≥1 mg/dL at baseline, the time to CRP normalization, as well as the percentage of patients with normalized CRP at both 8 and 26 weeks. Recurrent Pericarditis Recurrent pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) that follows an initial episode (frequently resulting from a viral infection). Patients may have multiple recurrences. 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. About 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 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: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), 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; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) 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 relating to 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 for primary efficacy endpoint and secondary endpoints, the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure, and the Company's anticipation that the totality of the MAvERIC-Pilot data will support advancing to a Phase III trial of CardiolRx™. 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. In addition, a decision to proceed with a Phase III trial is subject to full Phase II MAvERIC-Pilot study outcomes and regulatory authorization. Data from the Study is not necessarily indicative of results from future Phase III studies which may be conducted. 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. 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

临床结果临床2期孤儿药上市批准临床3期

2024-05-14

·BioSpace

Cardiol Therapeutics Announces Phase II ARCHER Trial Presented at the World Congress on Acute Heart Failure 2024

Scope of presentation included trial design, rationale, and blinded baseline data on first 50 patients randomized into the Phase II study evaluating CardiolRx™ in patients with acute myocarditis ARCHER trial rationale and design also accepted for publication in the journal ESC Heart Failure ARCHER trial has now exceeded 85% of target patient enrollment MAvERIC-Pilot Phase II study investigating CardiolRx™ for recurrent pericarditis expected to report topline results in early June 2024 Toronto, Ontario--(News - May 14, 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 its Phase II randomized, double-blind, placebo-controlled trial evaluating the impact of CardiolRx™ on myocardial recovery in patients with acute myocarditis ("ARCHER") was the subject of an oral presentation at the World Congress on Acute Heart Failure 2024, May 11 - 14 in Lisbon, Portugal - the annual congress of the Heart Failure Association of the European Society of Cardiology ("ESC"). The trial design, rationale, and blinded baseline data on the first 50 patients randomized into ARCHER was presented by Univ.-Prof. Dr. med. Carsten Tschöpe from the Berlin Institute of Health - Charité, on behalf of the ARCHER steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence who contributed to the design and execution of ARCHER. Concurrent with the presentation, the journal ESC Heart Failure, which is dedicated to advancing knowledge about heart failure worldwide, has accepted the manuscript describing the rationale and design of the ARCHER trial for publication. "Acceptance to present the ARCHER trial design at such a prestigious scientific meeting and pending publication of the manuscript is testament to the high level of interest from the cardiology community in novel approaches to treat acute myocarditis for which there are currently no therapies approved by European and United States regulatory authorities. The baseline data from the first 50 ARCHER patients reveal demographics expected in acute myocarditis. Importantly, the initial baseline values of the primary and secondary outcome measures assessing myocardial function reveal low variability and reflect patients with acute myocarditis which is consistent with the patient segment expected to benefit from CardiolRx™ therapy," commented David Elsley, President and Chief Executive Officer of Cardiol Therapeutics. "Patient recruitment has been accelerating due in large part to the growing global awareness of myocarditis and the interest and commitment demonstrated by our clinical collaborators and participating patients. We are pleased to report ARCHER has now exceeded 85% of target enrollment. We anticipate that results from the ARCHER trial will assist in furthering our understanding of the therapeutic potential of CardiolRx™ and will complement our more advanced MAvERIC-Pilot Phase II study in patients presenting with recurrent pericarditis, expected to report topline results in early June 2024." The ARCHER trial is expected to enroll 100 patients at pre-eminent cardiovascular research centers in the United States, Canada, France, Brazil, and Israel. The primary outcome measures of the trial, which will be evaluated following 12 weeks of double-blind therapy, consist of two cardiac magnetic resonance imaging measures: left ventricular function (longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis. Additional efficacy outcome measurements include left ventricular ejection fraction, survival, freedom from major cardiovascular events, resolution of clinical symptoms, and change in biomarkers associated with cardiac function and inflammation. 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 and commonly used drugs and mRNA vaccines, as well as therapies used to treat several common cancers, including chemo-therapeutic agents and immune checkpoint inhibitors. Patients hospitalized with the condition experience an average seven-day length of stay and a 4 - 6% risk of in-hospital mortality, with average hospital charge per stay estimated at $110,000 in the United States. About 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 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: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), 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; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) 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 relating to 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 for primary efficacy endpoint and secondary endpoints, the Company's plan to advance the development of CRD-38, a novel subcutaneous formulation of cannabidiol intended for use in heart failure, the ARCHER initial baseline values of the primary and secondary outcome measures assessing myocardial function are consistent with the patient segment expected to benefit from CardiolRx™ therapy, that results from the ARCHER trial will assist in furthering our understanding of the therapeutic potential of CardiolRx™ and will complement the MAvERIC-Pilot, and the Company's expectation to report topline results from MAvERIC-Pilot in early June 2024 and that these results will inform the design of a pivotal Phase III clinical trial in recurrent pericarditis to underpin the potential regulatory approval of CardiolRx™, and the Company's expectation to enroll 100 patients at pre-eminent cardiovascular research centers in North America, France, Brazil and Israel. 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 dated 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. 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

临床2期孤儿药

2024-04-02

·BioSpace

Cardiol Therapeutics Announces Year-End 2023 Update on Operations

Completed patient enrollment in the Phase II MAvERIC-Pilot study evaluating CardiolRx™ in patients with recurrent pericarditis, with topline results expected in Q2 2024 CardiolRx™ granted U.S. FDA Orphan Drug Designation for the treatment of pericarditis, which includes recurrent pericarditis Exceeded 50% enrollment in the Phase II ARCHER trial evaluating CardiolRx™ in patients with acute myocarditis; study expected to reach full enrollment during Q3 2024 Data presented at the HFSA Annual Scientific Sessions 2023 demonstrated that the API in Cardiol's novel CRD-38 formulation attenuates harmful fat distribution and key markers of cardiac inflammation and remodelling in a model of heart failure with preserved ejection fraction Cash and cash equivalents of $34.9 million as of December 31, 2023, which funds operations into 2026 Toronto, Ontario--(News - April 2, 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 announces its year-end 2023 update on operations following the filing of its audited Financial Statements and Management's Discussion and Analysis for the year ended December 31, 2023. Both are available under the Company's pro SEDAR+ at sedarplus.ca and on the Company's website at cardiolrx.com. "Cardiol Therapeutics made important progress in 2023 and early 2024 as we pursued our primary objective of providing new therapeutic options to patients with poorly served heart diseases," said David Elsley, President and Chief Executive Officer of Cardiol Therapeutics. "During 2023, we initiated patient recruitment in our MAvERIC-Pilot study in patients with recurrent pericarditis and are very pleased that this important study recently completed full target enrollment, positioning the Company to report topline results in the second quarter of 2024. Completion of patient enrollment in MAvERIC-Pilot was achieved shortly after receipt of U.S. FDA Orphan Drug Designation for CardiolRx™ for the treatment of pericarditis, a larger indication and potential market exclusivity than originally anticipated by the Company. Another noteworthy clinical milestone of 2023 culminated with reporting that our global ARCHER trial, which is evaluating CardiolRx™ in patients with acute myocarditis, exceeded 50% enrollment, and is now expected to complete full enrollment during the third quarter of 2024 which is ahead of the original timeline. Importantly, CardiolRx™ is also eligible for orphan drug designations for the treatment of acute myocarditis in both the United States and the European Union. In support of our ongoing clinical programs, we were pleased to have pre-clinical results presented by our collaborators at a number of cardiology-focused scientific meetings throughout 2023, providing additional insight into the molecular and cellular mechanisms of action and benefits of our drug candidates. Looking forward, with operations funded into 2026, Cardiol is well positioned to achieve significant milestones in the MAvERIC, ARCHER, and CRD-38 programs during 2024 that we believe will underpin business development initiatives aimed at accelerating our goal of delivering important new therapeutic options to people affected by underserved debilitating heart diseases." Key Highlights: Phase II MAvERIC-Pilot Study in Recurrent Pericarditis In January 2023, Cardiol announced the first patient had been enrolled in the Company's Phase II open-label pilot study ("MAvERIC-Pilot") investigating the tolerance, safety, and efficacy of CardiolRx™ in patients with recurrent pericarditis. In addition to standard safety assessments, the study is designed to evaluate improvement in objective measures of disease, and during an extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids, while taking CardiolRx™. In November 2023, Cardiol announced that it had exceeded 50% of the patient enrollment target for the MAvERIC-Pilot study. Furthermore, in December, Cardiol announced that Massachusetts General Hospital had been initiated and was eligible to enroll patients; adding to a pre-eminent group of medical research centers participating in the study that includes the Cleveland Clinic and the Mayo Clinic. In February 2024, CardiolRx™ was granted Orphan Drug Designation ("ODD") by the United States Food and Drug Administration ("FDA") for the treatment of pericarditis, a rare inflammatory heart disease. The FDA grants ODD to a drug or biological product to prevent, diagnose, or treat a rare disease or condition that affects fewer than 200,000 people in the United States. ODD provides benefits to sponsors including potential seven-year marketing exclusivity, exemptions from certain FDA fees, and tax credits for qualified clinical trials. Products with ODD may also qualify for accelerated regulatory review via Fast Track, Breakthrough Therapy, or Priority Review designations. In February 2024, Cardiol announced the completion of patient enrollment in MAvERIC-Pilot. In addition, the Company announced that it expects to report topline results from MAvERIC-Pilot in Q2 2024. Phase II ARCHER Trial in Acute Myocarditis In September 2023, Cardiol announced that all collaborating research centers had been initiated and were eligible to enroll patients in ARCHER, the Company's Phase II, multi-center, international, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx™, as well as its impact on myocardial recovery, in patients presenting with acute myocarditis. ARCHER is expected to enroll approximately 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel. In January 2024, Cardiol announced that ARCHER had exceeded 50% patient enrollment and was progressing ahead of the original study timeline. The Company anticipates completing full enrollment in Q3 2024. Given there are no FDA-approved therapies for acute myocarditis, Cardiol believes there is a significant opportunity to develop an important new therapy for acute myocarditis that would also be eligible for orphan designation in the United States and the European Union. Pre-Clinical/Clinical Developments In March, Cardiol announced study results were presented at the American College of Cardiology's 72nd Annual Scientific Session together with World Congress of Cardiology demonstrating that the active pharmaceutical ingredient ("API") in CardiolRx™ and CRD-38 (a novel subcutaneously administered formulation), significantly prevents cardiac dysfunction and the development of fibrosis and cardiomyocyte hypertrophy in a pre-clinical model of heart failure and reduces expression of key inflammatory and fibrotic markers. This work builds upon existing knowledge by confirming the cardioprotective properties of Cardiol's lead small molecule drug candidate and, in this model, its ability to reduce inflammation and prevent hypertrophy and fibrosis in heart tissue. A second poster presented data related to the role of the API in mitochondrial calcium dynamics in hypertrophic cells. The API was shown to prevent hypertrophy-induced mitochondrial calcium overload and prevent hypertrophy-induced increase of several mitochondrial function markers such as reactive oxygen species and calcium uptake. In addition, this work suggests that the API effects may rely on PPAR-γ activation, which in turn can inhibit NF-κB, a transcription factor that regulates pro-inflammatory and pro-hypertrophic genes. Together, these findings further clarify the API's mode of action in combatting cardiac hypertrophy. In October, Cardiol announced study results presented at the Heart Failure Society of America ("HFSA") Annual Scientific Meeting 2023 demonstrating that the subcutaneously administered formulation of the API slowed increases in body weight and heart weight and prevented increases in key cardiac inflammatory and remodelling markers in a pre-clinical model of heart failure with preserved ejection fraction. These findings expand the understanding of the cardioprotective effects of CRD-38 and suggest new therapeutic potential in heart failure, which remains a leading cause of death and hospital admissions in the United States and throughout the developed world, with associated healthcare costs in the United States exceeding US$30 billion annually. In November, Cardiol announced results from experiments conducted by its research collaborators at the University of Virginia and Houston Methodist DeBakey Heart & Vascular Center, that in an experimental model of pericarditis, the API induces mesothelial to mesenchymal transition ("MMT") and that this process is inhibited by treatment. The results presented were a continuation of a research collaboration between Cardiol and the University of Virginia, which previously reported at the American Heart Association Scientific Sessions 2022 that the API reduces pericardial effusion and thickness in the same experimental model of pericarditis. MMT is a complex and stepwise biological process whereby a mesothelial cell, the main cell type lining internal organs and several of the body's internal cavities including the pericardium, undergoes molecular reprogramming. This alters its characteristics towards a mesenchymal cell, such as a myofibroblast, which are the primary cells during wound healing and fibrosis. Mounting evidence indicates the transition to mesenchymal cells is involved in adult cardiovascular diseases, such as heart failure. Pericarditis leads to pericardial effusion and thickening that may evolve to fibrosis, and by limiting MMT and the ensuing fibrosis, CardiolRx™ may also represent a novel strategy to prevent pericarditis complications. About 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 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: (i) a Phase II multi-center open-label pilot study in recurrent pericarditis (the MAvERIC-Pilot study; NCT05494788), 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; and (ii) a Phase II multi-national, randomized, double-blind, placebo-controlled trial (the ARCHER trial; NCT05180240) 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 of cannabidiol 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 relating to 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 for primary efficacy endpoint and secondary endpoints, the Company's plan to advance the development of a novel subcutaneous formulation of CardiolRx™ for use in heart failure, and the Company's expectation to report topline results from MAvERIC-Pilot in the second quarter of 2024 and that these results will inform the design of a pivotal Phase III clinical trial in recurrent pericarditis to underpin the potential regulatory approval of CardiolRx™, the Company's plan to complete full enrollment of approximately 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel in the ARCHER trial during the third quarter of 2024, the Company's belief that its product candidates may be eligible for orphan drug designation in the United States and the European Union as a therapy for acute myocarditis, the Company's expectation that operations will be funded into 2026 and the Company's expectation that it will achieve significant corporate milestones during 2024. 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 dated 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. 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

临床2期孤儿药快速通道临床结果

100 项与 CardiolRx 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
心血管疾病	临床3期	-	-	2020-11-04
新型冠状病毒感染	临床3期	-	-	2020-11-04
心包炎	临床2期	美国	Cardiol Therapeutics, Inc.	2022-11-30
心肌炎	临床2期	美国	Cardiol Therapeutics, Inc.	2022-06-22
心肌炎	临床2期	巴西	Cardiol Therapeutics, Inc.	2022-06-22
心肌炎	临床2期	加拿大	Cardiol Therapeutics, Inc.	2022-06-22
心肌炎	临床2期	法国	Cardiol Therapeutics, Inc.	2022-06-22
心肌炎	临床2期	以色列	Cardiol Therapeutics, Inc.	2022-06-22
心脏衰竭	临床前	-	Cardiol Therapeutics, Inc.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03614663 (CONNECT-FX, CTgov)	临床2/3期	脆性X综合征	212	ZYN002 - Cannabidiol Transdermal Gel (ZYN002 - Cannabidiol Transdermal Gel)	廠壓積遞襯顧願構膚網(築範鹹繭顧餘糧夢鬱鹹) = 鏇夢築艱築膚鹽襯衊窪醖齋壓製鏇廠廠糧廠醖 (築積獵憲淵衊艱壓積範, 膚膚獵憲選獵憲膚憲獵 ~ 衊夢襯繭獵艱齋顧鹹襯) 更多	-	2022-06-16
				Placebo Transdermal Gel (Placebo Transdermal Gel)	膚築顧繭鏇築糧繭蓋壓(糧願觸觸觸選憲夢選積) = 繭憲選襯艱範艱繭齋壓醖襯齋鹽蓋窪構繭鹽鹹 (鹹餘鹽選膚觸窪遞窪糧, 艱憲積壓構淵齋壓淵築 ~ 壓觸獵衊廠壓鹽鬱醖餘) 更多