Topline Results from GALACTIC-HF, Phase 3 Clinical Trial of Omecamtiv Mecarbil, Cardiac Myosin Activator, Expected in Q4
Licensing Collaboration and Royalty Monetization Deals with Xi Jing Pharmaceuticals and RTW Investments Accelerate and Expand Development of CK-3773274, Next Generation Cardiac Myosin Inhibitor
Leveraging Partnerships to Finance Build of Commercial Business
SOUTH SAN FRANCISCO, Calif., July 15, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) management plans to provide updates on the company’s advancing cardiovascular pipeline and strategies to build a commercial franchise at “Activate. Inhibit. Empower: Changing the Course of Cardiovascular Disease,” a Virtual Analyst & Investor Event, today at 8:30 AM Eastern Time. As the treatment landscape in heart failure and hypertrophic cardiomyopathies is rapidly evolving, the event will also feature commentary and perspectives from leading physician experts and patient advocates.
“This is a transformative time for Cytokinetics as we execute against our Vision 2025 to be the leading muscle biology focused company dedicated to meaningfully improving the lives of patients with diseases of impaired muscle function through access to novel medicines arising from our research,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Our cardiovascular pipeline is among the most innovative in the biopharmaceutical industry with a combination of first-in-class and next-generation cardiac myosin activators and inhibitors, being developed independently and in collaboration with partners. We believe these potential medicines may alter the course of diseases of impaired cardiac contractility and successfully transition Cytokinetics into a fully integrated biopharmaceutical company.”
“Our pioneering research has led to the discovery of novel cardiac drug candidates that modulate sarcomere function by either increasing or decreasing cardiovascular biomechanics and contractility,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President, Research & Development. “An integrated suite of purpose-built technologies has enabled our ability to impact to develop investigational medicines that are designed to address a broad array of phenotypes in heart failure that, despite available pharmaceutical and surgical interventions, represent large unmet needs among patients worldwide.”
Omecamtiv Mecarbil: Cardiac Myosin Activator (Heart Failure)
Management will present an overview of the clinical development program for omecamtiv mecarbil featuring a review of GALACTIC-HF, (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), a large, Phase 3, global, event-driven, cardiovascular outcomes trial of omecamtiv mecarbil from which results are expected in Q4 2020 and METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a second Phase 3 clinical trial of omecamtiv mecarbil, designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity. Omecamtiv mecarbil is being developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF) under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier. The company will also present results from previous trials including COSMIC-HF, a Phase 2 trial of omecamtiv mecarbil, and discuss cardiovascular biomarkers end endpoints correlative with outcomes.
CK-3773274 (CK-274): Cardiac Myosin Inhibitor (Hypertrophic Cardiomyopathy (HCM))
Management will also present a review of recent progress with CK-274 the company’s next-in-class cardiac myosin inhibitor, including a review of the Phase 1 data supportive of the design and conduct of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), a Phase 2 clinical trial which began enrollment earlier this year and has resumed following a brief suspension in enrollment due to COVID-19. In addition, the team will discuss additional plans for the development of CK-274 in cardiovascular diseases associated with hypercontractility.
Cardiovascular Franchise Strategy
In preparation for potential commercialization of omecamtiv mecarbil, the company will highlight strategic plans to leverage its leadership in cardiac muscle biology to develop and commercialize innovative medicines for cardiovascular diseases, with initial focus to heart failure with reduced ejection fraction (HFrEF) and hypertrophic cardiomyopathies (HCM). Company management will elaborate on its business strategy to leverage its corporate partnerships and focus to improve the healthspan of patients with cardiovascular disease by enabling them to feel better, function better, and live longer.
Physician Experts and Patient Advocates
At today’s Virtual Analyst & Investor Day, a panel of leading physician experts in the treatment of heart failure and HCM will discuss opportunities and perspectives on the changing landscape in heart failure therapy and emerging treatments for HCM. Panelists include:
- John McMurray, M.D., Professor of Medical Cardiology & Honorary Consultant Cardiologist, Institute of Cardiovascular & Medical Sciences, British Heart Foundation Cardiovascular Research Centre, University of Glasgow
- Adrian Hernandez, M.D., MHS, Executive Director, Duke Clinical Research Institute, Vice Dean, Duke University School of Medicine
- Larry Allen, M.D., MHS, Professor of Medicine, Kenneth Poirier Chair; Associate Head for Clinical Affairs, Cardiology; Medical Director, Advanced Heart Failure, University of Colorado School of Medicine
- Martin Maron, M.D., Director Hypertrophic Cardiomyopathy Center, Tufts Medical Center and Chanin T. Mast Hypertrophic Cardiomyopathy Center, Morristown Medical Center
- Anjali Tiku Owens, M.D., Medical Director, Center for Inherited Cardiac Disease, Assistant Professor of Medicine, University of Pennsylvania
- Andrew Wang, M.D., Professor of Medicine, Vice Chief for Clinical Services, Duke University School of Medicine
In addition, a panel of patients with heart failure and HCM will discuss living with cardiovascular diseases and their interests and objectives in engaging together with colleagues in the advocacy community.
Access to Virtual Event
Interested parties may access today’s live virtual event by registering online at https://bit.ly/CYTKInvestorDay or by visiting the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. An archived replay of the virtual event will be available via Cytokinetics’ website until July 15, 2021.
About Omecamtiv Mecarbil and the Phase 3 Clinical Trials Program
Omecamtiv mecarbil is a novel, selective cardiac myosin activator, also known as a cardiac myotrope,1 that binds to the catalytic domain of myosin. Preclinical research has shown that omecamtiv mecarbil increases cardiac contractility without increasing intracellular myocyte calcium concentrations or myocardial oxygen consumption. Cardiac myosin is the cytoskeletal motor protein in the cardiac muscle cell that is directly responsible for converting chemical energy into the mechanical force resulting in cardiac contraction. 2-4
Omecamtiv mecarbil is being developed for the potential treatment of heart failure with reduced ejection fraction (HFrEF) under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier. Omecamtiv mecarbil is the subject of a comprehensive Phase 3 clinical trials program comprised of GALACTIC-HF, a Phase 3 clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on cardiovascular outcomes and METEORIC-HF, a Phase 3 clinical trial designed to evaluate the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity.
About CK-274 and REDWOOD-HCM
CK-274 is a novel, oral, small molecule cardiac myosin inhibitor that company scientists discovered independent of its collaborations. CK-274 arose from an extensive chemical optimization program conducted with careful attention to therapeutic index and pharmacokinetic properties that may translate into next-in-class potential in clinical development. CK-274 was designed to reduce the hypercontractility that is associated with hypertrophic cardiomyopathy (HCM). In preclinical models, CK-274 reduces myocardial contractility by binding directly to cardiac myosin at a distinct and selective allosteric binding site, thereby preventing myosin from entering a force producing state. CK-274 reduces the number of active actin-myosin cross bridges during each cardiac cycle and consequently reduces myocardial contractility.
REDWOOD-HCM is a multi-center, randomized, placebo-controlled, double-blind, dose-finding Phase 2 clinical trial in patients with symptomatic, obstructive HCM. The primary objective of the trial is to determine the safety and tolerability of CK-274. The secondary objectives are to describe the concentration-response and dose-response relationship of CK-274 on the resting and post-Valsalva left ventricular outflow tract gradient as measured by echocardiography during 10 weeks of treatment.
About Cytokinetics and Amgen Collaboration
In 2006, Cytokinetics and Amgen entered into a strategic alliance to discover, develop and commercialize novel small molecule therapeutics designed to activate the cardiac sarcomere for the potential treatment of heart failure. Omecamtiv mecarbil is being developed by Amgen in collaboration with Cytokinetics, with funding and strategic support from Servier. Amgen holds an exclusive, worldwide license to omecamtiv mecarbil and related compounds, subject to Cytokinetics' specified development and commercialization rights. Cytokinetics is eligible for pre-commercialization and commercialization milestone payments and royalties that escalate based on increasing levels of annual net sales of products commercialized under the agreement. Cytokinetics has co-invested with Amgen in the Phase 3 development program of omecamtiv mecarbil in exchange for increased royalties from Amgen on worldwide sales of omecamtiv mecarbil outside Japan and co-promotion rights in institutional care settings in North America. Amgen has also entered an alliance with Servier for exclusive commercialization rights for omecamtiv mecarbil in Europe as well as the Commonwealth of Independent States, including Russia.
About Cytokinetics and Ji Xing Pharmaceuticals/RTW Investments Collaboration
Cytokinetics has granted Ji Xing Pharmaceuticals Limited an exclusive license to develop and commercialize CK-274 in China and Taiwan, in accordance with Cytokinetics’ planned global registration programs. Cytokinetics will receive an upfront payment and is eligible to receive development and commercial milestone payments and royalties on future sales of CK-274 in China and Taiwan. Under a separate funding agreement, Cytokinetics has received options for additional funding from investment funds managed by RTW Investments, LP for the further development of CK-274 in hypertrophic cardiomyopathies in exchange for royalties on future sales of CK-274 in the United States and certain European countries.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF and METEORIC-HF. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA) for the potential treatment of ALS and other neuromuscular indications following conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The company is considering potential advancement of reldesemtiv to Phase 3 pending ongoing regulatory interactions. Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas) to research, develop and commercialize other novel mechanism skeletal sarcomere activators (not including FSTAs). Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies (HCM). Cytokinetics has granted Ji Xing Pharmaceuticals Limited an exclusive license to develop and commercialize CK-274 in China and Taiwan, in accordance with Cytokinetics’ planned global registration programs. Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.
For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter, 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 relating to the GALACTIC-HF clinical trial, including the expected timing of the availability of top-line results; statements relating to the METEORIC-HF clinical trial; the potential benefits of omecamtiv mecarbil, including its ability to represent a novel therapeutic strategy to increase cardiac muscle function and restore cardiac performance; statements relating to the REDWOOD-HCM clinical trial; statements relating to the potential benefits of CK-274; statements relating to our interactions with regulatory authorities in connection to the potential advancement of a Phase 3 clinical trial of reldesemtiv in patients with ALS; the potential benefits of reldesemtiv; Cytokinetics' and its partners' research and development activities; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of Cytokinetics' other drug candidates. 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' or its partners' ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; the nature of Amgen's decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; the nature of Ji Xing's decisions with respect to the design, initiation, conduct, timing and continuation of development activities for CK-274, standards of care may change, rendering Cytokinetics' drug candidates obsolete; competitive products or alternative therapies may be developed by others for the treatment of indications Cytokinetics' drug candidates and potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners and licensees, including milestones and royalties on future potential product sales under Cytokinetics' collaboration and license agreements with such partners. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
Contact:
Diane Weiser
Senior Vice President, Corporate Communications, Investor Relations
(415) 290-7757
References
- Psotka MA, Gottlieb SS, Francis GS et al. Cardiac Calcitropes, Myotropes, and Mitotropes. JACC. 2019; 73:2345-53.
- Planelles-Herrero VJ, Hartman JJ, Robert-Paganin J. et al. Mechanistic and structural basis for activation of cardiac myosin force production by omecamtiv mecarbil. Nat Commun. 2017;8:190.
- Shen YT, Malik FI, Zhao X, et al. Improvement of cardiac function by a cardiac myosin activator in conscious dogs with systolic heart failure. Circ Heart Fail. 2010; 3: 522-27.
- Malik FI, Hartman JJ, Elias KA, Morgan BP, Rodriguez H, Brejc K, Anderson RL, Sueoka SH, Lee KH, Finer JT, Sakowicz R. Cardiac myosin activation: a potential therapeutic approach for systolic heart failure. Science. 2011 Mar 18;331(6023):1439-43.