Cytokinetics(US:CYTK)2025-09-02 13:32Summary of Conference Call on Aficamtan and MAPLE HCM Study Company and Industry - Company: Cytokinetics - Industry: Cardiovascular Pharmaceuticals, specifically focusing on treatments for obstructive hypertrophic cardiomyopathy (HCM) Key Points and Arguments Overview of Aficamtan and MAPLE HCM Study - Aficamtan is a cardiac myosin inhibitor aimed at treating obstructive hypertrophic cardiomyopathy (OHCM) [7][9] - The MAPLE HCM study is a Phase III clinical trial comparing aficamtan to the standard beta blocker metoprolol in patients with OHCM [8][17] - The study demonstrated that aficamtan improved exercise capacity, while metoprolol resulted in a decrease in exercise capacity [9][21] Study Results - Aficamtan showed a statistically significant mean increase in peak VO2 of 1.1 mL/kg/min compared to a decrease of 1.2 mL/kg/min in the metoprolol group, with a mean difference of 2.3 mL/kg/min (p < 0.001) [21] - Secondary endpoints, including improvements in symptoms, NT proBNP levels, and left atrial volume index, were statistically significant in favor of aficamtan [22][24] - Aficamtan was well tolerated, with fewer patients needing to discontinue treatment due to adverse events compared to metoprolol [25][26] Clinical Implications - The results challenge the long-standing use of beta blockers as the first-line treatment for symptomatic OHCM, suggesting aficamtan may be a superior option [9][27] - The study highlights the need for updated clinical guidelines to reflect the new evidence supporting aficamtan as a first-line therapy [76][78] Expert Perspectives - Experts expressed that the findings from MAPLE HCM were groundbreaking, indicating that beta blockers may not be as effective as previously thought [31][34] - The excitement at the European Society of Cardiology (ESC) congress was palpable, with many attendees recognizing the significance of the trial results [32][33] Future Directions - Cytokinetics is preparing to submit a supplemental NDA to include MAPLE HCM results in the labeling of aficamtan following its potential approval [80] - The company anticipates sharing results from the ongoing Acacia HCM study in 2026, which will further inform the treatment landscape for HCM [81] Other Important Content - The call included discussions on the implications of the results for non-obstructive HCM and the challenges faced in clinical trials for this population [56][60] - The panelists emphasized the importance of individualized treatment approaches and the need for further research to understand the mechanisms underlying non-obstructive HCM [70][72] This summary encapsulates the critical findings and discussions from the conference call regarding aficamtan and its implications for the treatment of obstructive hypertrophic cardiomyopathy.