Cytokinetics Announces Initiation of Phase 1 Clinical Study of CK-4015089
Cytokinetics (CYTK) has initiated a Phase 1 clinical study of CK-4015089 (CK-089), a fast skeletal muscle troponin activator (FSTA). The trial is a randomized, double-blind, placebo-controlled study evaluating safety, tolerability, and pharmacokinetics in healthy participants. The study includes single and multiple ascending dose cohorts, each with 10 participants. CK-089 showed promising pre-clinical results, increasing muscle force and function in animal models, suggesting potential applications in muscular dystrophy and other conditions of impaired muscle function.
Cytokinetics (CYTK) ha avviato uno studio clinico di Fase 1 per CK-4015089 (CK-089), un attivatore della troponina muscolare scheletrica veloce (FSTA). Lo studio è un trial randomizzato, in doppio cieco e controllato con placebo che valuta sicurezza, tollerabilità e farmacocinetica in partecipanti sani. Lo studio include coorti di dosi ascendenti singole e multiple, ognuna con 10 partecipanti. CK-089 ha mostrato risultati preclinici promettenti, aumentando la forza e la funzione muscolare in modelli animali, suggerendo potenziali applicazioni nella distrofia muscolare e in altre condizioni di disfunzione muscolare.
Cytokinetics (CYTK) ha iniciado un estudio clínico de Fase 1 para CK-4015089 (CK-089), un activador de troponina de músculo esquelético rápido (FSTA). El ensayo es un estudio aleatorizado, doble ciego y controlado con placebo que evalúa la seguridad, la tolerabilidad y la farmacocinética en participantes sanos. El estudio incluye cohortes de dosis ascendentes únicas y múltiples, cada una con 10 participantes. CK-089 mostró resultados preclínicos prometedores, aumentando la fuerza y la función muscular en modelos animales, lo que sugiere aplicaciones potenciales en distrofias musculares y otras condiciones de función muscular deteriorada.
사이토키네틱스 (CYTK)는 CK-4015089 (CK-089)에 대한 1상 임상 연구를 시작했습니다. 이는 빠른 골격근 트로포닌 활성제(FSTA)입니다. 이 연구는 건강한 참가자들을 대상으로 안전성, 내약성 및 약물 동태를 평가하는 무작위 이중 맹검 플라세보 대조 연구입니다. 연구는 각 10명의 참가자가 포함된 단일 및 다중 용량 상승 코호트를 포함합니다. CK-089는 동물 모델에서 근력과 기능을 증가시키는 유망한 전임상 결과를 보여주며, 근육형성이상증 및 기타 근육 기능 장애 상태에서의 잠재적 응용 가능성을 시사합니다.
Cytokinetics (CYTK) a lancé une étude clinique de phase 1 pour CK-4015089 (CK-089), un activateur de la troponine musculaire squelettique rapide (FSTA). L'essai est une étude randomisée, en double aveugle et contrôlée par placebo évaluant la sécurité, la tolérance et la pharmacocinétique chez des participants sains. L'étude comprend des cohortes de doses ascendantes uniques et multiples, chacune composée de 10 participants. CK-089 a montré des résultats précliniques prometteurs, augmentant la force et la fonction musculaire dans des modèles animaux, suggérant des applications potentielles dans la dystrophie musculaire et d'autres conditions de dysfonction musculaire.
Cytokinetics (CYTK) hat eine Phase-1-Studie zu CK-4015089 (CK-089) initiiert, einem schnellen Aktivator des Skelettmuskel-Troponins (FSTA). Die Studie ist eine randomisierte, doppelblinde, placebo-kontrollierte Studie zur Bewertung der Sicherheit, Verträglichkeit und Pharmakokinetik bei gesunden Probanden. Die Studie umfasst Kohorten mit einzelnen und mehrfachen aufsteigenden Dosen, jeweils mit 10 Teilnehmern. CK-089 zeigte vielversprechende präklinische Ergebnisse, die die Muskelkraft und -funktion bei Tiermodellen steigern und potenzielle Anwendungen bei Muskeldystrophie und anderen Bedingungen mit beeinträchtigter Muskelfunktion nahelegen.
- Successful advancement to Phase 1 clinical trials with CK-089
- Promising pre-clinical results showing increased muscle force and function
- Expansion of pipeline in neuromuscular diseases
- None.
Insights
The initiation of Phase 1 trials for CK-4015089 marks a strategic expansion of Cytokinetics' neuromuscular disease pipeline. This fast skeletal muscle troponin activator (FSTA) has shown promising preclinical results in increasing muscle force and function, particularly relevant for specific muscular dystrophy conditions.
The trial design follows standard Phase 1 protocols, incorporating both single and multiple ascending dose cohorts with 10 participants each. While this early-stage development is important for pipeline diversity, investors should note that the company explicitly states their specialty cardiology franchise remains the priority. This suggests CK-089 represents a longer-term value proposition rather than a near-term catalyst.
The preclinical data indicating improved muscle function in disease models provides a solid foundation, but as with all Phase 1 trials, the focus will be primarily on safety and pharmacokinetics rather than efficacy. The market for muscular dystrophy treatments is substantial, though commercialization would be years away pending successful trials.
Advancement of Fast Skeletal Muscle Troponin Activator Expands Pipeline of Muscle-Directed Drug Candidates
SOUTH SAN FRANCISCO, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the first participants have been dosed in a Phase 1 randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose clinical study of CK-4015089 (CK-089) in healthy human participants. CK-089 is a fast skeletal muscle troponin activator (FSTA) with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired muscle function.
“We are pleased to begin clinical development of CK-089, a promising fast skeletal muscle troponin activator arising from our research in neuromuscular diseases,” said Stuart Kupfer, M.D., Senior Vice President, Chief Medical Officer. “In the pre-clinical setting, CK-089 increased muscle force and function in animal models of a neuromuscular disease characterized by muscle weakness, atrophy and fatigue, suggesting it may have therapeutic application to a specific type of muscular dystrophy but also other conditions of impaired muscle function. While our specialty cardiology franchise remains our top priority, CK-089 represents a unique opportunity to leverage our expertise in muscle biology to potentially make a difference for patients living with neuromuscular diseases of impaired muscle function.”
Phase 1 Clinical Trial Design
The primary objective of this Phase 1 randomized, double-blind, placebo-controlled, multi-part single and multiple ascending dose clinical study is to evaluate the safety, tolerability and pharmacokinetics of CK-089 when administered orally as single or multiple doses to healthy participants. The study design includes single ascending dose cohorts and multiple-dose ascending cohorts comprised of 10 participants each.
About CK-4015089
CK-4015089 (CK-089) is a novel, selective, oral, small molecule fast skeletal muscle troponin activator (FSTA) with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired muscle function. CK-089 is designed to selectively activate the fast skeletal muscle troponin complex by increasing its affinity for calcium. CK-089 has a different chemical structure from previously developed FSTAs and in preclinical research, has been observed to have higher bioavailability, solubility and pharmacodynamic efficacy. In preclinical models, CK-089 improved muscle force and function in a mouse model with a specific type of muscular dystrophy associated with muscle weakness and fatigue.
About Cytokinetics
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing muscle biology-directed drug candidates as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility. Following positive results from SEQUOIA-HCM, the pivotal Phase 3 clinical trial evaluating aficamten, a next-in-class cardiac myosin inhibitor, in obstructive hypertrophic cardiomyopathy (HCM), Cytokinetics submitted an NDA for aficamten to the U.S. Food & Drug Administration and is progressing regulatory submissions for aficamten for the treatment of obstructive HCM in Europe. Aficamten is also currently being evaluated in MAPLE-HCM, a Phase 3 clinical trial of aficamten as monotherapy compared to metoprolol as monotherapy in patients with obstructive HCM, ACACIA-HCM, a Phase 3 clinical trial of aficamten in patients with non-obstructive HCM, CEDAR-HCM, a clinical trial of aficamten in a pediatric population with obstructive HCM, and FOREST-HCM, an open-label extension clinical study of aficamten in patients with HCM. Cytokinetics is also developing omecamtiv mecarbil, a cardiac muscle 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 (FSTA) with potential therapeutic application to a specific type of muscular dystrophy and other conditions of impaired 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 potential benefits of CK-089 in specific types of muscular dystrophy and other conditions of impaired muscle function. 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.
Contact:
Cytokinetics
Diane Weiser
Senior Vice President, Corporate Affairs
(415) 290-7757
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