Cytokinetics, Incorporated (Nasdaq: CYTK) is making strides in its cardiac myosin modulation programs, highlighted by the recent submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for aficamten in Q3 2024. This announcement was part of the company's Investor and Analyst Day, where updates on clinical trials and commercial launch readiness were shared.
Advancing Cardiac Myosin Modulation
Robert I. Blum, Cytokinetics’ President and Chief Executive Officer, emphasized the company's commitment to addressing unmet patient needs in hypertrophic cardiomyopathy (HCM) and heart failure through myosin modulation. "Our pioneering science relating to the mechanics of cardiac muscle function continues to be the engine empowering Cytokinetics," he stated.
COMET-HF: Phase 3 Trial of Omecamtiv Mecarbil
Cytokinetics is set to initiate COMET-HF (Confirmation of Omecamtiv Mecarbil Efficacy Trial in Heart Failure), a Phase 3 multi-center, double-blind, randomized, placebo-controlled trial. This trial will evaluate the efficacy and safety of omecamtiv mecarbil in patients with symptomatic heart failure with severely reduced ejection fraction.
The primary endpoint of COMET-HF is the time to first event in a composite endpoint including cardiovascular death, first heart failure event, LVAD implantation or cardiac transplantation, or stroke. Approximately 1,800 patients will be enrolled and randomized 1:1 to receive omecamtiv mecarbil or placebo. The trial is expected to begin in Q4 2024.
AMBER-HFpEF: Phase 2 Trial of CK-586
Also planned for Q4 2024 is the start of AMBER-HFpEF (Assessment of CK-586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF), a Phase 2 randomized, placebo-controlled, double-blind, multi-center, dose-finding clinical trial in patients with symptomatic HFpEF with left ventricular ejection fraction (LVEF) ≥60%. The primary objective is to assess the safety and tolerability of CK-586 compared to placebo.
Global Commercial Launch Readiness for Aficamten
With the NDA for aficamten submitted, Cytokinetics is actively preparing for a potential U.S. launch in 2025. Commercial strategies are focused on differentiated market access and patient experience. Activities include ongoing payer engagement and publication of health economics and outcomes research.
Cytokinetics has also launched "HCM Beyond the Heart," an unbranded disease awareness campaign for healthcare professionals, to highlight the challenges faced by individuals living with HCM.
In Europe, the company plans to submit a Marketing Authorization Application (MAA) for aficamten to the European Medicines Agency (EMA) in Q4. Engagement with European payers, key opinion leaders, and patient advocacy groups is underway to prepare for potential approval and launch.
