Cytokinetics(US:CYTK)2025-09-02 13:30Cytokinetics (CYTK) Update Summary Company Overview - Company: Cytokinetics (CYTK) - Focus: Development of aficamtan for the treatment of obstructive hypertrophic cardiomyopathy (OHCM) Key Industry Insights - Industry: Cardiovascular Medicine - Event: European Society of Cardiology (ESC) Conference Core Findings from the Call 1. Presentation of Data: Cytokinetics presented four oral presentations and one poster on aficamtan, with three publications in leading cardiac journals, emphasizing its potential as a treatment for OHCM [7][8][27] 2. MAPLE HCM Study: The Phase III trial compared aficamtan to metoprolol, showing aficamtan's superiority in improving exercise capacity and reducing symptoms [8][26] 3. Efficacy Results: - Aficamtan showed a mean increase in peak VO2 of 1.1 mL/kg/min, while metoprolol showed a mean decrease of 1.2 mL/kg/min, with a statistically significant difference of 2.3 mL/kg/min (p < 0.001) [21][26] - Aficamtan improved NT proBNP levels by 81% compared to baseline, while metoprolol's levels increased [24][26] 4. Safety Profile: Aficamtan was well tolerated with a low incidence of adverse events, contrasting with metoprolol, which had a higher rate of dose reductions due to side effects [25][26] 5. Long-term Data: Data from FORWEST HCM indicated sustained hemodynamic benefits and low incidence of new onset atrial fibrillation over a mean follow-up of 62 weeks [11][12] Implications for Treatment 1. Shift in Treatment Paradigm: The results challenge the long-standing use of beta blockers as first-line therapy for symptomatic obstructive HCM, suggesting aficamtan as a more effective alternative [8][31] 2. Guideline Updates: Anticipation of updates to clinical guidelines to incorporate findings from MAPLE HCM and other studies, with a focus on aficamtan as a first-line therapy [77][79] Additional Insights 1. Expert Perspectives: Panelists highlighted the importance of randomized clinical trials in reshaping treatment approaches and the surprising underperformance of beta blockers in the study [33][36] 2. Future Studies: Ongoing studies, including Acacia HCM, are expected to provide further insights into the efficacy of aficamtan in different patient populations [82] 3. Regulatory Pathway: Cytokinetics is preparing a supplemental NDA to include MAPLE HCM results in labeling following the potential approval of aficamtan [81][82] Conclusion - The data presented at the ESC conference significantly bolster the case for aficamtan as a first-line treatment for obstructive HCM, potentially leading to a paradigm shift in clinical practice and future treatment guidelines [26][31][81]