Top-line Results from GALACTIC-HF Now Expected in Q4 2020; Commercial Readiness Underway
REDWOOD-HCM Initiated; Second Cardiac Myosin Inhibitor Planned to Enter Clinic in 1H 2020
SOUTH SAN FRANCISCO, Calif., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq: CYTK) today announced its Vision 2025 and provided guidance for corporate milestones expected to occur in 2020. The company’s Vision 2025: “Leading with Science, Delivering for Patients,” articulates its five-year key imperatives enabling Cytokinetics to be the leading muscle biology biopharmaceutical company that meaningfully improve the lives of patients with diseases of impaired muscle function through access to novel medicines arising from its research.
Key imperatives for Vision 2025 include:
- Achieve regulatory approvals for at least two drugs arising from our pipeline
- Build commercial capabilities to market and sell our medicines reflective of their innovation and value
- Generate sustainable and growing revenues from product sales
- Double our development pipeline to include ten therapeutic programs
- Expand our discovery platform to muscle energetics, growth and metabolism
- Be the science-driven company people want to join and partner with
“Our company transformation began five years ago when we outlined our Vision 2020,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We effectively executed on those initiatives so that we are now well positioned to look forward to the next five-year horizon and the profound privilege to potentially bring forward to patients at least two new medicines from our pioneering muscle biology focused research. We expect to deliver on the promise of our science and to double our pipeline of novel mechanism drug candidates and expand the breadth of our discovery platform. As we execute against our vision, we will support disease advocacy groups elevating the patient voice and live by our values of integrity, fairness and compassion in all that we do.”
In addition, the company announced its expected 2020 milestones.
“To ensure that we deliver on the promise of our science for patients, we recognize that we must continue to plan and execute well in connection with expected milestones in 2020,” continued Mr. Blum. “This will be a pivotal year for Cytokinetics as we now expect trial results from GALACTIC-HF by the end of the year and we need to prepare commercial readiness and co-promotion plans accordingly. In addition, we expect to both advance and expand our pipeline to enable two other programs to potentially advance to late-stage trials while another two programs may advance in earlier-stage trials. We look forward to another highly productive year aligned with our vision.”
Expected 2020 Milestones
Cardiac Muscle Programs
Omecamtiv mecarbil (cardiac myosin activator)
- Second interim analysis of GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 cardiovascular outcomes clinical trial of omecamtiv mecarbil, in Q1 2020.
- Topline results from GALACTIC-HF in Q4 2020.
- Complete enrollment in METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), the second Phase 3 trial of omecamtiv mecarbil, in 2020.
- Conduct commercial readiness and develop co-promotion plan in collaboration with Amgen in 2020.
AMG 594 (cardiac troponin activator)
- Complete Phase 1 SAD/MAD study of AMG 594 in 2H 2020.
CK-3773274 (CK-274, cardiac myosin inhibitor)
- Conduct REDWOOD-HCM, the Phase 2 clinical trial of CK-274 designed to determine the safety and tolerability of CK-274 in patients with obstructive hypertrophic cardiomyopathy (oHCM), in 2020.
CK-3772271 (CK-271, cardiac myosin inhibitor)
- File IND and initiate Phase 1 study in 1H 2020.
Skeletal Muscle Programs
Reldesemtiv (fast skeletal muscle troponin activator, FSTA)
- Engage with regulatory and reimbursement authorities in 2020 to prepare for a potential Phase 3 clinical trial and registration program for reldesemtiv in patients with ALS (amyotrophic lateral sclerosis).
CK-3762601 (CK-601, next-generation FSTA)
- Advance CK-601 in IND-enabling studies in 2020.
- Continue research activities directed to the cardiac and skeletal sarcomere and our other muscle biology research programs.
- Expect to continue research in collaboration with Astellas directed to the discovery of next-generation skeletal muscle activators through 2020, subject to current negotiations.
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 collaborating with Astellas Pharma Inc. (Astellas) to develop reldesemtiv, a fast skeletal muscle troponin activator (FSTA). Astellas currently holds an exclusive worldwide license to develop and commercialize reldesemtiv. 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 is conducting REDWOOD-HCM, a Phase 2 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.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics 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 Cytokinetics’ and its partners’ research and development and commercial readiness activities, including the initiation, conduct, design, enrollment, progress, continuation, completion, timing and results of clinical trials, Cytokinetics’ ability to ensure commercial readiness and develop co-promotion plans in collaboration with Amgen; the significance and utility of pre-clinical study and clinical trial results; planned interactions with regulatory authorities and the outcomes of such interactions, including discussions in preparation for a potential Phase 3 clinical trial and registration program for reldesemtiv in patients with ALS; the expected timing of events and milestones; and the properties and potential benefits of Cytokinetics’ 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 Cytokinetics’ need for additional funding and such additional funding may not be available on acceptable terms, if at all; 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; patient enrollment for or conduct of clinical trials may be difficult or delayed; the FDA or foreign regulatory agencies may delay or limit Cytokinetics’ or its partners’ ability to conduct clinical trials; Amgen’s and Astellas’ decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil and reldesemtiv, respectively; Cytokinetics may incur unanticipated research and development and other costs; 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. 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.
Vice President, Corporate Communications, Investor Relations
Source: Cytokinetics, Incorporated