Cytokinetics Announces Initiation of Phase 1 Study of Aficamten in Healthy Japanese Participants

Core Insights - Cytokinetics is conducting a Phase 1 bridging study to evaluate the pharmacokinetics of aficamten in healthy Japanese adults, which is essential for potential approval in Japan [1][9] - Aficamten is a selective cardiac myosin inhibitor designed to reduce myocardial hypercontractility associated with hypertrophic cardiomyopathy (HCM) [2] - The company plans to submit a New Drug Application (NDA) to the FDA in Q3 2024 and a Marketing Authorization Application (MAA) to the EMA in Q4 2024 [6] Company Overview - Cytokinetics is a late-stage biopharmaceutical company focused on developing first-in-class muscle activators and next-in-class muscle inhibitors for diseases affecting cardiac muscle performance [14] - The company has a history of innovation in muscle biology and pharmacology, targeting conditions of muscle dysfunction and weakness [7] Clinical Development - The Phase 1 study will involve 70 healthy participants, including both Japanese and Caucasian individuals, to assess the pharmacokinetics, safety, and tolerability of aficamten [5] - Aficamten is also being evaluated in multiple Phase 3 clinical trials, including MAPLE-HCM, ACACIA-HCM, and CEDAR-HCM, focusing on different patient populations with HCM [11] Regulatory Pathway - Aficamten has received Breakthrough Therapy Designation from the FDA for the treatment of symptomatic obstructive HCM, indicating its potential significance in addressing this condition [6] - The company is preparing for regulatory submissions in both the U.S. and Europe, with expectations to file applications within the next year [6][7]