A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Assess Efficacy and Safety of Omecamtiv Mecarbil in Patients with Symptomatic Heart Failure with Severely Reduced Ejection Fraction (COMET-HF)

The purpose of this study is to find out if the investigational drug called omecamtiv mecarbil can reduce the risk of the effects of heart failure, like hospitalization, transplantation, or death in patients with heart failure and severely reduced ejection fraction.

开始日期2024-12-19

申办/合作机构

Cytokinetics, Inc.

NCT04464525

/ Withdrawn临床3期

Omecamtiv Mecarbil Post-trial Access Protocol for Subjects Completing Study 20110203 GALACTIC-HF

The primary objective of this study is to provide access to omecamtiv mecarbil for participants who have completed GALACTIC-HF 20110203.

开始日期2020-12-18

申办/合作机构

Cytokinetics, Inc.

EUCTR2020-003057-30-PT

/ Not yet recruiting临床3期

Omecamtiv Mecarbil Post-trial Access Protocol for Subjects Completing Study 20110203 GALACTIC-HF - Omecamtiv Mecarbil Post-trial Access Protocol

开始日期2020-11-13

申办/合作机构

Amgen, Inc.

100 项与 Omecamtiv Mecarbil 相关的临床结果

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100 项与 Omecamtiv Mecarbil 相关的转化医学

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100 项与 Omecamtiv Mecarbil 相关的专利（医药）

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312

项与 Omecamtiv Mecarbil 相关的文献（医药）

2025-01-01·AMERICAN JOURNAL OF PHYSIOLOGY-HEART AND CIRCULATORY PHYSIOLOGY

Differential effects of myosin activators on myocardial contractile function in nonfailing and failing human hearts

Article

作者: Dominic, Katherine L ; Wood, Patrick T ; Campbell, Kenneth S ; Choi, Joohee ; Holmes, Joshua B ; Stelzer, Julian E ; Dos Remedios, Cristobal G

This is the first study to provide a detailed mechanistic comparison of omecamtiv mecarbil (OM) and danicamtiv (DN) in failing and nonfailing human myocardium. These findings have clinical implications and the potential to inform the clinical utility of myosin activators in the heart failure setting.

2024-12-01·Physiological Reports

Induction of cardiac alternans in human iPS‐derived cardiomyocytes through β‐adrenergic receptor stimulation

Article

作者: Matsuura, Katsuhisa ; Shimizu, Tatsuya ; Hinata, Yuto ; Sasaki, Daisuke

Abstract:

Cardiac alternans (C‐ALT) is a phenomenon of alternating strong and weak contractions in the heart and is considered a risk factor for the development of heart failure and arrhythmias. However, no model has been reported that can induce C‐ALT in vitro using human cells, and the developmental mechanism of C‐ALT has not been studied using human cells. In this study, we successfully induced C‐ALT in vitro using human‐induced pluripotent stem cell‐derived cardiomyocytes (hiPSC‐CMs). By stimulating β‐adrenergic receptor with isoproterenol on hiPSC‐CMs cultured in atmospheric condition (with ~0.04% CO2), contractility and calcium transient were observed to alternately increase and decrease with each beat. In contrast, C‐ALT was not induced in hiPSC‐CMs cultured at 5% CO2 concentration. Since previous studies have linked C‐ALT to problems with calcium regulation in the sarcoplasmic reticulum (SR), we exposed hiPSC‐CMs to compounds that alter SR Ca2+ loading and analyzed their contractile responses. The results showed that exposure to verapamil, thapsigargin, and ryanodine either suppressed or eliminated C‐ALT. In contrast, omecamtiv mecarbil and blebbistatin, which alter contractility without SR Ca2+ loading, did not induce or suppress C‐ALT. These results suggest that C‐ALT in hiPSC‐CMs induced by isoproterenol may be due to abnormal regulation of the ryanodine receptor's opening and closing caused by excessive Ca2+ load in the SR from β‐adrenergic receptor stimulation.

2024-09-10·INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

Myosin Isoform-Dependent Effect of Omecamtiv Mecarbil on the Regulation of Force Generation in Human Cardiac Muscle.

Article

作者: Piroddi, Nicoletta ; Ferrantini, Cecilia ; Poggesi, Corrado ; Tesi, Chiara ; Pioner, J Manuel ; Dente, Marica ; Scellini, Beatrice

Omecamtiv mecarbil (OM) is a small molecule that has been shown to improve the function of the slow human ventricular myosin (MyHC) motor through a complex perturbation of the thin/thick filament regulatory state of the sarcomere mediated by binding to myosin allosteric sites coupled to inorganic phosphate (Pi) release. Here, myofibrils from samples of human left ventricle (β-slow MyHC-7) and left atrium (α-fast MyHC-6) from healthy donors were used to study the differential effects of μmolar [OM] on isometric force in relaxing conditions (pCa 9.0) and at maximal (pCa 4.5) or half-maximal (pCa 5.75) calcium activation, both under control conditions (15 °C; equimolar DMSO; contaminant inorganic phosphate [Pi] ~170 μM) and in the presence of 5 mM [Pi]. The activation state and OM concentration within the contractile lattice were rapidly altered by fast solution switching, demonstrating that the effect of OM was rapid and fully reversible with dose-dependent and myosin isoform-dependent features. In MyHC-7 ventricular myofibrils, OM increased submaximal and maximal Ca²⁺-activated isometric force with a complex dose-dependent effect peaking (40% increase) at 0.5 μM, whereas in MyHC-6 atrial myofibrils, it had no effect or-at concentrations above 5 µM-decreased the maximum Ca²⁺-activated force. In both ventricular and atrial myofibrils, OM strongly depressed the kinetics of force development and relaxation up to 90% at 10 μM [OM] and reduced the inhibition of force by inorganic phosphate. Interestingly, in the ventricle, but not in the atrium, OM induced a large dose-dependent Ca²⁺-independent force development and an increase in basal ATPase that were abolished by the presence of millimolar inorganic phosphate, consistent with the hypothesis that the widely reported Ca²⁺-sensitising effect of OM may be coupled to a change in the state of the thick filaments that resembles the on-off regulation of thin filaments by Ca²⁺. The complexity of this scenario may help to understand the disappointing results of clinical trials testing OM as inotropic support in systolic heart failure compared with currently available inotropic drugs that alter the calcium signalling cascade.

216

项与 Omecamtiv Mecarbil 相关的新闻（医药）

2025-01-22

·PRNewswire

Chronic Heart Failure Market to Observe Stunning Growth at a CAGR of 10% by 2034 Owing to Strong Uptake of Entresto and approved SGLT2 Inhibitors along with Emergence of New Class of Therapies | DelveInsight

Several leading classes of therapies are exploring diverse mechanisms of action to treat CHF, including SGLT2 inhibitors, cardiac myosin activators, myeloperoxidase inhibitors, mineralocorticoid receptor antagonists, GLP-1 receptor agonists, cell therapies, and more. This growing focus is expected to drive the chronic heart failure market forward. In summary, the existing blockbuster therapies such as Entresto, recently approved SGLT2 inhibitors, and Soluble guanylate cyclase (sGC) stimulators, along with emerging cell therapies, peptides, monoclonal antibodies, and small molecules, together have the potential to drive the existing market along with securing a significant market share upon introduction of new entrants to the CHF treatment landscape. LAS VEGAS, Jan. 22, 2025 /PRNewswire/ -- DelveInsight's Chronic Heart Failure Market Insights report includes a comprehensive understanding of current treatment practices, chronic heart failure emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Chronic Heart Failure Market Report According to DelveInsight's analysis, the market size for chronic heart failure was found to be approximately USD 5.5 billion in the US in 2023. Among the 7MM, the US contributed the largest market share of the total CHF market size and will continue to experience a steep rise in the market size throughout the forecast period. As per DelveInsight's estimate, the total diagnosed prevalent cases of CHF in the 7MM were approximately 20 million in 2023. Heart failure with preserved ejection fraction (HFpEF) contributed to most of the cases. Within class-specific diagnosed prevalence of Heart failure, NYHA class II and class III contribute the maximum. Established chronic heart failure companies with approved therapies in the market are Novartis, Otsuka, Boehringer Ingelheim/Eli Lilly, Bayer/Merck, Amgen/Servier, scPharmaceuticals, and Lexicon Pharmaceuticals/Viatris. In addition, Daiichi Sankyo and American Regent are targeting adult patients with heart failure who are iron deficient. Among all the approved therapies, Novartis and Otsuka's Entresto, approved since 2015 in the US, is still the leading therapy generating more than USD 4 billion in the 7MM in 2023. Among, Eli Lilly's Jardiance and AstraZeneca's Farxiga, both SGLT2 inhibitors, Farxiga is the leading prescribed SGLT2 inhibitor globally by volume Leading chronic heart failure companies developing emerging therapies, such as Cytokinetics, Bayer, Eli Lilly, BioCardia, Mesoblast, Tenax Therapeutics, Novo Nordisk, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Intra-Cellular Therapies, Cardurion Pharmaceuticals, Rivus Pharmaceuticals, and others are developing novel chronic heart failure drugs that can be available in the chronic heart failure market in the coming years. The promising chronic heart failure therapies in the pipeline include Omecamtiv Mecarbil, KERENDIA (finerenone), Tirzepatide (LY3298176), CardiAMP Cell Therapy, Ziltivekimab (NN6018), REVASCOR (rexlemestrocel-L), Levosimendan (TNX-103), Semaglutide, Balcinrenone (AZD9977) + dapagliflozin, Mitiperstat (AZD4831), Vicadrostat (BI 690517) + Empagliflozin, Cimlanod (CXL-1427/BMS-986231), Lenrispodun (ITI - 214), CRD-740, HU6, and others. In October 2024, Viatris entered into an exclusive licensing agreement with Lexicon Pharmaceuticals for INPEFA (sotagliflozin) in all markets outside of the US and EU. In September 2024, Bayer presented the late-breaking data of Phase III FINE-HEART findings of KERENDIA (finerenone) during a Hot Line session at the European Society of Cardiology (ESC) Congress 2024. In May 2024, Eli Lilly and Company committed an additional USD 5.3 billion manufacturing investment in the company's newest Indiana site to boost API production for tirzepatide and pipeline medicines. AstraZeneca expects the data of the Phase III BalanceD-HF trial of balcinrenone (AZD9977) + dapagliflozin for heart failure in 2025. Discover which therapies are expected to grab the major chronic heart failure market share @ Chronic Heart Failure Market Report Chronic Heart Failure Overview Chronic heart failure is a long-term condition in which the heart's ability to pump blood efficiently is reduced, leading to inadequate circulation of oxygen and nutrients to meet the body's needs. The primary causes of CHF include coronary artery disease, high blood pressure, diabetes, cardiomyopathy, valvular heart disease, and previous heart attacks. Lifestyle factors like obesity, smoking, excessive alcohol consumption, and a sedentary lifestyle can also contribute to its development. The symptoms of CHF vary in severity and may include persistent fatigue, shortness of breath, swelling in the legs, ankles, or abdomen, rapid or irregular heartbeat, and difficulty exercising. Advanced cases can lead to severe fluid retention, wheezing, and an inability to carry out daily activities. Diagnosis typically involves a comprehensive medical history review and a physical examination, followed by tests like an ECG to assess heart rhythm, echocardiography to evaluate heart structure and function, blood tests, chest X-rays, and stress tests. Early diagnosis and management are crucial to improving quality of life and preventing complications. Chronic Heart Failure Epidemiology Segmentation The chronic heart failure epidemiology section provides insights into the historical and current chronic heart failure patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The chronic heart failure market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Heart Failure Gender-specific Cases of Heart Failure Ejection Fraction-specific Cases of Heart Failure New York Heart Association (NYHA) Class-specific Cases of Heart Failure Type-specific Cases of Heart Failure Age-specific Cases of Heart Failure Chronic Heart Failure Treatment Market Current treatments for heart failure primarily rely on angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), beta-blockers, and diuretics. Additional therapies, such as aldosterone antagonists, amiodarone, antiplatelets, anticoagulants, calcium channel blockers, and nitrates, are also utilized in managing the condition. Most treatment regimens involve a combination of therapies, with beta-blockers being among the most commonly prescribed. Among the approved treatments, Novartis' ENTRESTO has emerged as a leading drug in the congestive heart failure market. Initially slow to gain traction, ENTRESTO has become one of Novartis' key growth drivers, with revenue expected to increase in the coming years. Following its approval for use in patients with preserved ejection fraction, ENTRESTO's market presence has grown significantly. However, ENTRESTO faces growing competition. The entry of new drugs, including SGLT2 inhibitors (such as FARXIGA and JARDIANCE) and VERQUVO, poses a challenge to ENTRESTO's dominance. Additionally, Novartis is set to lose ENTRESTO's exclusivity in the United States in 2025, raising the risk of generic competition. The company is actively engaged in several patent lawsuits to protect its position. SGLT2 inhibitors have also gained a foothold in the CHF market. Although FARXIGA and JARDIANCE are established drugs, they are relatively new in this therapeutic area. The outlook for SGLT2 inhibitors in heart failure is promising, but AstraZeneca and Lilly/Boehringer will have limited time to solidify their positions, as FARXIGA's US patent expires in 2025 and JARDIANCE's in 2028. The recently approved SGLT2 inhibitor sotagliflozin may face challenges in capturing market share from these established treatments. To know more about chronic heart failure treatment guidelines, visit @ Chronic Heart Failure Management Chronic Heart Failure Pipeline Therapies and Key Companies Omecamtiv Mecarbil: Cytokinetics KERENDIA (finerenone): Bayer Tirzepatide (LY3298176): Eli Lilly and Company CardiAMP Cell Therapy: BioCardia Ziltivekimab (NN6018): Novo Nordisk REVASCOR (rexlemestrocel-L): Mesoblast Levosimendan (TNX-103): Tenax Therapeutics Semaglutide: Novo Nordisk Balcinrenone (AZD9977) + dapagliflozin: AstraZeneca Mitiperstat (AZD4831): AstraZeneca Vicadrostat (BI 690517) + Empagliflozin: Boehringer Ingelheim Cimlanod (CXL-1427/BMS-986231): Bristol Myers Squibb Lenrispodun (ITI - 214): Intra-Cellular Therapies CRD-740: Cardurion Pharmaceuticals HU6: Rivus Pharmaceuticals Discover more about chronic heart failure drugs in development @ Chronic Heart Failure Clinical Trials Chronic Heart Failure Market Dynamics The chronic heart failure market dynamics are expected to change in the coming years. An increasing prevalence of cardiovascular diseases, fueled by aging populations and lifestyle-related risk factors such as obesity, hypertension, and diabetes, has significantly raised the demand for effective CHF treatments. Advances in medical technology, including innovative drug therapies, cardiac devices, and regenerative medicine, are expanding treatment options and improving patient outcomes. Growing awareness about heart health and early diagnosis, supported by government and non-government initiatives, is also boosting market expansion. Additionally, the rising focus on personalized medicine and the development of therapies targeting the underlying molecular mechanisms of CHF are creating lucrative opportunities. The increasing healthcare expenditure and the availability of reimbursement policies in developed and emerging economies further bolster the market's growth trajectory. Furthermore, potential therapies are being investigated for the treatment of chronic heart failure, and it is safe to predict that the treatment space will significantly impact the chronic heart failure market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the chronic heart failure market in the 7MM. However several factors may impede the growth of the chronic heart failure market. A key challenge is the underdiagnosis and delayed recognition of CHF due to overlapping symptoms with other conditions and the lack of widespread access to advanced diagnostic tools in many regions. Economic constraints, particularly in low- and middle-income countries, limit patient access to costly therapies, including advanced drugs and devices. Additionally, adherence to treatment regimens remains low due to the complexity of management protocols and the long-term nature of care, leading to suboptimal outcomes. Regulatory hurdles and lengthy approval processes for novel therapies further impede the introduction of innovative treatments. Finally, a limited understanding among general practitioners about newer guidelines and therapies reduces the referral rates to specialists, creating gaps in patient care. Addressing these barriers requires concerted efforts in education, affordability, and healthcare infrastructure. Scope of the Chronic Heart Failure Market Report Therapeutic Assessment: Chronic Heart Failure current marketed and emerging therapies Chronic Heart Failure Market Dynamics: Key Market Forecast Assumptions of Emerging Chronic Heart Failure Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Chronic Heart Failure Market Access and Reimbursement Download the report to understand which factors are driving chronic heart failure market trends @ Chronic Heart Failure Market Trends Table of Contents Related Reports Chronic Heart Failure Epidemiology Forecast Chronic Heart Failure Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology as well as the chronic heart failure epidemiology trends. Chronic Heart Failure Pipeline Chronic Heart Failure Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CHF companies, including Zensun (Shanghai) Sci & Tech, Cytokinetics, Mesoblast, Shanghai Hongyitang Biopharmaceutical Technology, Tasly Pharmaceuticals, Ionis Pharmaceuticals, Berlin Cures, CardioCell, Help Therapeutics, Eli Lilly and Company, Chong Kun Dang Pharmaceutical, Antlia Biosciences, Cardiol Therapeutics, among others. Acute Coronary Syndrome Market Acute Coronary Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ACS companies, including Novartis, Boehringer Idorsia Pharmaceuticals, Viatris, Recardio, AstraZeneca, Faraday Pharmaceuticals, DalCor Pharmaceuticals, Roche, Jiangsu Vcare PharmaTech, CeleCor Therapeutics, Novo Nordisk, Bristol Myers Squibb, Johnson & Johnson Innovative Medicine, CellProthera, BioCardia, Kancera, Amgen, Arrowhead Pharmaceuticals, Abcentra , among others. Acute Coronary Syndrome Pipeline Acute Coronary Syndrome Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key acute coronary syndrome companies, including Janssen Research & Development, LLC, DalCor Pharmaceuticals, Hyloris Pharmaceuticals, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期上市批准引进/卖出

2025-01-21

·ir.cytokinetics.com

Cytokinetics Announces Start of AMBER-HFpEF, a Phase 2 Clinical Trial of CK-586 in Patients With Symptomatic Heart Failure With Preserved Ejection Fraction

SOUTH SAN FRANCISCO, Calif., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that AMBER-HFpEF (Assessment of CK-586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF) is open to enrollment. AMBER-HFpEF is a Phase 2 randomized, placebo-controlled, double-blind, multi-center, dose-finding clinical trial of CK-4021586 (CK-586) in patients with symptomatic heart failure with preserved ejection fraction (HFpEF) with left ventricular ejection fraction (LVEF) ≥60%. CK-586 is a cardiac myosin inhibitor in development for the potential treatment of a subgroup of with symptomatic HFpEF patients with hypercontractility and ventricular hypertrophy. “We are pleased to be advancing CK-586 into a Phase 2 trial in a subset of patients with symptomatic HFpEF,” said Stuart Kupfer, M.D., Senior Vice President, Chief Medical Officer. “Despite recent advances in available treatments, patients with heart failure with supranormal ejection fraction continue to have a poor prognosis following hospitalization. Evaluating CK-586 in this Phase 2 trial further extends the potential of our cardiac myosin directed development platform focused to specialty cardiology indications.” Approximately half of patients with heart failure have HFpEF, characterized by an ejection fraction of at least 50%, impaired diastolic function and elevated NTpro-BNP, which can lead to poor ventricular compliance and reduced cardiac output. A subset of patients with HFpEF resemble patients with non-obstructive hypertrophic cardiomyopathy (nHCM) in that those patients have higher ejection fractions and thickened walls of their heart in association with elevated cardiac biomarkers and symptoms of heart failure. The evaluation of CK-586 in HFpEF builds on the similarity of these conditions and the data accumulated to date with aficamten in nHCM. About AMBER-HFpEF AMBER-HFpEF is a Phase 2 randomized, placebo-controlled, double-blind, multi-center, dose-finding clinical trial in patients with symptomatic HFpEF with LVEF ≥60%. The primary objective is to evaluate the safety and tolerability profile of CK-586 compared to placebo. The secondary objectives include assessing the effect of CK-586 on LVEF and NT-proBNP, and determining both its pharmacokinetics and its pharmacokinetic/pharmacodynamic relationship. A number of exploratory endpoints will evaluate the effect of CK-586 on patient function, symptoms, and measures of cardiac function. AMBER-HFpEF is planned to enroll approximately 60 patients randomized on a 3:1 basis to receive CK-586 or placebo in three dose escalation cohorts. Patients will receive up to two escalating doses of CK-586 over 12 weeks or placebo. An echocardiogram at Week 6 will determine whether patients will be up-titrated to the higher dose. Once-daily doses of 150 mg and 300 mg are planned in Cohort 1, 300 mg and 450 mg in Cohort 2 and 450 mg and 600 mg in Cohort 3. At screening, patients enrolled in AMBER-HFpEF must have LVEF ≥60%, NT-proBNP ≥300 pg/mL for participants in sinus rhythm and ≥900 pg/mL for participants with atrial fibrillation or flutter (AFF), and be New York Heart Association (NYHA) Functional Class II or III. Additional information can be found on www.clinicaltrials.gov. About CK-4021586 (CK-586) CK-4021586 (CK-586) is designed to be a novel, selective, oral, small molecule cardiac myosin inhibitor designed to reduce the hypercontractility associated with heart failure with preserved ejection fraction (HFpEF). CK-586 was designed to selectively inhibit the ATPase of intact cardiac myosin but does not inhibit the ATPase of subfragment-1 of myosin (S1). The inhibitory effect of CK-586 requires the presence of the regulatory light chain (RLC) of myosin in the context of the intact myosin dimer (heavy meromyosin or HMM). In preclinical models, CK-586 reduced cardiac hypercontractility by decreasing the number of active myosin cross-bridges during cardiac contraction thereby reducing the contractile force, without effect on calcium transients. In engineered human HCM heart tissues, CK-586 demonstrated shallow force-concentration response and improved lusitropy. A subset of patients with HFpEF resemble patients with non-obstructive hypertrophic cardiomyopathy (nHCM) in that those patients have higher ejection fractions, thickened walls of their heart, elevated biomarkers, and symptoms of heart failure. Data from a Phase 2 clinical trial of aficamten, another investigational cardiac myosin inhibitor being developed by Cytokinetics, showed that in patients with nHCM aficamten was well tolerated, improved patient reported outcomes (Kansas City Cardiomyopathy Questionnaire (KCCQ) and New York Heart Association (NYHA) Functional Class) and biomarkers, measures that are also relevant to HFpEF. Aficamten was also well-tolerated with no drug discontinuations due to adverse events and no adverse events of heart failure. These data provide support for investigating this mechanism of action in HFpEF. About Heart Failure with Preserved Ejection Fraction Heart failure is a grievous condition that affects more than 64 million people worldwide.1 Approximately 6.7 million Americans have heart failure, which is expected to increase to over 8.5 million Americans by 2030.2 Approximately half of patients with heart failure have heart failure with preserved ejection fraction (HFpEF)3, and the prevalence of HFpEF is increasing.2,4 Approximately 75% of patients with HFpEF will die within five years of initial hospitalization, and 84% will be rehospitalized.2 Despite broad use of standard treatments and advances in care, the prognosis for patients with heart failure is poor.5 A subset of HFpEF patients with hypercontractility, ventricular hypertrophy, elevated biomarkers and symptoms of heart failure may benefit from treatment with a cardiac sarcomere inhibitor. About Cytokinetics Cytokinetics is a late-stage, muscle biology specialty biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, Cytokinetics is intent on meaningfully improving the lives of patients through global access to innovative medicines. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a potential next-in-class cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act's Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements, express or implied, relating to the Company’s development plans for CK-586 in the United States, including its ability to full enroll AMBER-HFpEF by any particular date, if at all. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, potential difficulties or delays in the development, testing, regulatory approvals for trial commencement, progression or product sale or manufacturing, or production of Cytokinetics' drug candidates that could slow or prevent clinical development or product approval; Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics' ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; standards of care may change, rendering Cytokinetics' drug candidates obsolete; and competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission. CYTOKINETICS® and the C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. References: Contact: Cytokinetics Diane Weiser Senior Vice President, Corporate Affairs (415) 290-7757 Source: Cytokinetics, Incorporated

临床2期临床3期临床结果

2025-01-13

·ir.cytokinetics.com

Cytokinetics Announces 2025 Corporate Milestones and Vision 2030

PDUFA Target Action Date for Aficamten Set for September 26, 2025; Commercial Launch Preparations Underway for First Potential Approval Five-Year Aspirations Outline Corporate Strategies to Becoming Leading Muscle Biology Specialty Biopharma Company SOUTH SAN FRANCISCO, Calif., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq: CYTK) today provided guidance for corporate milestones expected to occur in 2025 and outlined its aspirational Vision 2030, five-year strategic objectives designed to propel Cytokinetics to becoming the leading muscle-focused specialty biopharmaceutical company intent on meaningfully improving the lives of patients through global access to innovative medicines. “In 2025 we are poised for a defining year with principal focus to the potential approval and commercial launch of aficamten for obstructive HCM in the United States. At the same time, we are executing on a robust clinical trials development program for aficamten inclusive of MAPLE-HCM, with results expected in the first half of this year as may potentially support the use of aficamten as monotherapy,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “In addition, we are advancing our later-stage development programs for omecamtiv mecarbil and CK-586 in adjacent specialty cardiology indications with intention to further augment our pipeline over time. Cytokinetics is well positioned to prudently and meaningfully deliver increased shareholder value as we continue to execute well on key milestones and position the company to achieve longer-term aspirations defining of our Vision 2030.” Expected 2025 Milestones Cardiac Muscle Programs Aficamten (cardiac myosin inhibitor) Advance go-to-market strategies and prepare to commercially launch aficamten in the U.S. in 2H 2025, subject to approval by the U.S. Food & Drug Administration (FDA). Continue go-to-market plans in Germany and expand commercial readiness activities in Europe in 2025, in preparation for potential approval by the European Medicines Agency (EMA) in 1H 2026. Coordinate with Sanofi to support the potential approval of aficamten in China in 2H 2025, pending approval by the National Medical Products Administration (NMPA). Report topline results from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM), the Phase 3 clinical trial comparing aficamten as monotherapy to metoprolol as monotherapy in patients with symptomatic obstructive HCM, in 1H 2025. Complete patient enrollment of ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM), the pivotal Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, in 2H 2025. Complete enrollment of the adolescent cohort in CEDAR-HCM (Clinical Evaluation of Dosing with Aficamten to Reduce Obstruction in a Pediatric Population in HCM), a clinical trial of aficamten in a pediatric population with symptomatic obstructive HCM, in 2H 2025. Omecamtiv mecarbil (cardiac myosin activator) Continue patient enrollment in COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a confirmatory Phase 3 clinical of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction (HFrEF) through 2025 to enable completion of enrollment in 2026. CK-586 (cardiac myosin inhibitor) Complete enrollment of the first two patient cohorts in AMBER-HFpEF, (Assessment of CK-586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF), a Phase 2 clinical trial of CK-586 in patients with symptomatic heart failure with preserved ejection fraction (HFpEF) in 2H 2025. Skeletal Muscle Program CK-089 (fast skeletal muscle troponin activator) Complete the Phase 1 study of CK-089 in healthy human participants in 2025. Ongoing Research Continue ongoing pre-clinical development and research activities directed to additional muscle biology focused programs. Vision 2030 The Company also outlined its Vision 2030: “Empowering Muscle, Empowering Lives” with the following objectives: Innovation: Advance two approved products across three indications and ten novel molecular entities (NMEs) in our pipeline. Ignition: Achieve broad access and rapid use of our medicines in >15 countries throughout North America and Europe. Impact: Reach >100,000 patients globally with our medicines. Inspiration: Foster a patient-centric culture with emphasis on equitable access. Ingenuity: Extend our leadership in muscle biology deploying multiple therapeutic modalities. “Our Vision 2030 provides the aspirational roadmap, aligned with our corporate five-year strategic plan, that will propel us forward as a fully integrated and leading specialty biopharma company intent on delivering innovative medicines to patients around the world,” said Mr. Blum. “Vision 2030 articulates ambitious company goals to deliver product approvals, achieve broad access to our medicines, promote equitable access and advance our pioneering research to benefit patients, shareholders and employees.” About Cytokinetics Cytokinetics is a late-stage, muscle biology specialty biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, Cytokinetics is intent on meaningfully improving the lives of patients through global access to innovative medicines. Cytokinetics is readying for potential regulatory approvals and commercialization of aficamten, a next-in-class cardiac myosin inhibitor following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial in patients with obstructive hypertrophic cardiomyopathy (HCM). Aficamten is also being evaluated in additional clinical trials enrolling patients with obstructive and non-obstructive HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac myosin activator, in patients with heart failure with severely reduced ejection fraction (HFrEF), CK-586, a cardiac myosin inhibitor with a mechanism of action distinct from aficamten, for the potential treatment of heart failure with preserved ejection fraction (HFpEF) and CK-089, a fast skeletal muscle troponin activator with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired skeletal muscle function. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements express or implied relating to the properties or potential benefits of aficamten or any of our other drug candidates, our ability to obtain regulatory approval for aficamten for the treatment of obstructive hypertrophic cardiomyopathy or any other indication from FDA or any other regulatory body in the United States or abroad on a timely basis, or at all, the labeling or post-marketing conditions that FDA or another regulatory body may require in connection with the approval of aficamten, our ability to timely enroll and complete the ACACIA-HCM, AMBER-HFpEF, CEDAR-HCM, COMET-HF or CK-089 clinical trials, our ability to timely report the results of the MAPLE-HCM trial, and our ability achieve any element of our Vision 2030. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics’ business outlines in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS and C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. Contact: Cytokinetics Diane Weiser Senior Vice President, Corporate Affairs (415) 290-7757 Source: Cytokinetics, Incorporated

临床3期临床2期上市批准临床1期

100 项与 Omecamtiv Mecarbil 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09648	Omecamtiv Mecarbil	-	DB11816

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
心脏衰竭	申请上市	美国	Cytokinetics, Inc.	2022-02-04
慢性心力衰竭	申请上市	欧盟	Cytokinetics, Inc.	-
射血分数降低的心力衰竭	临床3期	美国	Cytokinetics, Inc.	2019-04-09
射血分数降低的心力衰竭	临床3期	加拿大	Cytokinetics, Inc.	2019-04-09
射血分数降低的心力衰竭	临床3期	法国	Cytokinetics, Inc.	2019-04-09
射血分数降低的心力衰竭	临床3期	德国	Cytokinetics, Inc.	2019-04-09
射血分数降低的心力衰竭	临床3期	匈牙利	Cytokinetics, Inc.	2019-04-09
射血分数降低的心力衰竭	临床3期	意大利	Cytokinetics, Inc.	2019-04-09
射血分数降低的心力衰竭	临床3期	荷兰	Cytokinetics, Inc.	2019-04-09
射血分数降低的心力衰竭	临床3期	波兰	Cytokinetics, Inc.	2019-04-09

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临床结果

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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


NCT02929329 (GALACTIC-HF, Pubmed \| JACC Heart Fail)	临床3期	射血分数降低的慢性心力衰竭 \| 胎儿水肿 \| 慢性心力衰竭 natriuretic peptides	-	Omecamtiv mecarbil	遞窪簾鑰鬱壓衊鹹鬱夢(齋膚夢夢觸構築積顧淵): adjusted HR = 0.8 (95% CI, 0.73 ~ 0.88) 更多	积极	2023-12-01
				Placebo
NCT03759392 (METEORIC-HF, CTgov)	临床3期	射血分数降低的心力衰竭	276	Omecamtiv Mecarbil (Omecamtiv Mecarbil)	顧築鏇艱糧鹽鏇範壓鑰(顧夢遞廠膚鹹築餘衊憲) = 膚網鹹鏇廠夢網襯觸顧願願願願廠鬱範鬱膚淵 (構構獵衊遞網廠蓋醖網, 製廠蓋憲鹹鬱範鏇顧襯 ~ 繭醖遞廠鹽齋網窪憲廠) 更多	-	2023-03-07
				Placebo (Placebo)	顧築鏇艱糧鹽鏇範壓鑰(顧夢遞廠膚鹹築餘衊憲) = 齋顧觸構鏇壓夢鑰製鏇願願願願廠鬱範鬱膚淵 (構構獵衊遞網廠蓋醖網, 觸襯選鹹艱膚糧築鏇壓 ~ 願淵廠窪獵構觸選觸夢) 更多
NCT02929329 (GALACTIC-HF, Pubmed \| Eur J Heart Fail)	N/A	射血分数降低的心力衰竭	8,232	Omecamtiv mecarbil	構淵繭繭鏇膚鹹蓋餘壓(襯鑰構蓋遞夢膚壓膚鹹): HR = 0.94 (95% CI, 0.8 ~ 1.09), P-Value = 0.095	-	2023-01-04
				Placebo
ESC2022	N/A	心脏衰竭	-	Omecamtiv mecarbil	顧壓製選憲壓艱壓網膚(顧鏇網鬱積餘糧窪網網): OR = 0.99 (95% CI, 0.9 ~ 1.1), P-Value = 0.91 更多	不佳	2022-08-28
				Placebo
NCT03759392 (METEORIC-HF, Pubmed) 人工标引	临床3期	慢性心力衰竭	276	Omecamtiv Mecarbil	鹽壓艱鏇淵獵衊構簾衊(淵製鹽夢範餘選繭願襯) = 衊積獵製廠製壓壓鹹積鏇積築膚鹹遞構鹹獵範 (壓網蓋觸襯鏇鹹廠鑰憲 ) 更多	不佳	2022-07-19
				Placebo	鹽壓艱鏇淵獵衊構簾衊(淵製鹽夢範餘選繭願襯) = 廠積衊糧築廠築齋鬱襯鏇積築膚鹹遞構鹹獵範 (壓網蓋觸襯鏇鹹廠鑰憲 ) 更多
ESC2022	N/A	射血分数降低的心力衰竭	-	Omecamtiv Mecarbil	築鏇夢壓鬱廠鹽選選衊(鏇製製網廠鬱蓋範膚憲): RR = 1.0 (95% CI, 0.93 ~ 1.07) 更多	-	2022-04-07
				Placebo
NCT02929329 (GALACTIC-HF, Pubmed \| JAMA Cardiol)	临床3期	心脏衰竭	8,232	Omecamtiv mecarbil	艱鬱築糧繭繭淵積觸鏇(淵製製餘襯繭淵積衊鏇): HR = 0.88 (95% CI, 0.75 ~ 1.03)	-	2021-10-13
				Placebo
NCT02929329 (GALACTIC-HF, CTgov)	临床3期	射血分数降低的慢性心力衰竭 \| 胎儿水肿 \| 慢性心力衰竭	8,256	Placebo (Placebo)	壓齋願鏇製齋構鏇夢積(選蓋窪積餘簾製襯淵窪) = 廠簾夢遞艱壓繭夢網糧膚遞淵鹽獵製範淵憲糧 (選淵構選窪窪壓齋製糧, 願艱鬱糧齋壓鏇鹹鏇醖 ~ 窪簾膚憲製築廠選齋窪) 更多	-	2021-07-20
				Standard of Care+Omecamtiv Mecarbil (Omecamtiv Mecarbil)	壓齋願鏇製齋構鏇夢積(選蓋窪積餘簾製襯淵窪) = 襯壓繭廠顧襯網積製齋膚遞淵鹽獵製範淵憲糧 (選淵構選窪窪壓齋製糧, 齋淵齋醖醖艱襯積範繭 ~ 廠構蓋鑰構憲繭構網鹽) 更多
NCT02929329 (GALACTIC-HF, Pubmed \| J Am Coll Cardiol)	N/A	射血分数降低的慢性心力衰竭 \| 胎儿水肿 \| 慢性心力衰竭	-	Omecamtiv Mecarbil	鬱獵鑰製構範鹽鑰窪網(醖範齋選製憲憲簾鏇糧): Hazard Ratio = 0.83 (95% CI, 0.73 ~ 0.95)	积极	2021-04-28
				Placebo
NCT02929329 (GALACTIC-HF, Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床3期	收缩性心力衰竭	8,232	Omecamtiv Mecarbil	簾鑰顧選廠艱範網鹹糧(繭積餘選製範廠膚鏇範) = 製淵憲顧積淵築願鑰願窪窪願鏇衊構膚廠襯鹽 (艱鹽蓋遞窪窪餘鬱壓獵 ) 更多	积极	2021-01-14
				Placebo	簾鑰顧選廠艱範網鹹糧(繭積餘選製範廠膚鏇範) = 願網襯繭鬱願窪積觸鬱窪窪願鏇衊構膚廠襯鹽 (艱鹽蓋遞窪窪餘鬱壓獵 ) 更多