Cytokinetics announced the primary results from the MAPLE-HCM trial at the European Society of Cardiology Congress 2025.
The trial demonstrated the superiority of Aficamten over the standard-of-care beta-blocker Metoprolol in treating obstructive hypertrophic cardiomyopathy (oHCM).
Results showed that Aficamten significantly improved exercise capacity compared to Metoprolol in patients with oHCM.
Superiority of Aficamten
Aficamten was shown to be superior to Metoprolol in improving exercise capacity and functional outcomes in patients with oHCM.
Consistent Endpoint Results
The primary endpoint results from MAPLE-HCM were consistent across all prespecified subgroups, highlighting the effectiveness of Aficamten.
Regulatory Review
Aficamten is currently under FDA review with a target action date of December 26, 2025, showing potential for future regulatory approval.
- The results of MAPLE-HCM indicate a significant advancement in the treatment of obstructive HCM, challenging the traditional use of beta-blockers as the primary treatment modality.
- Aficamten's impact on improving exercise capacity and reducing symptoms in a broader patient population showcases its potential as a promising therapy for oHCM.
The positive outcomes of the MAPLE-HCM trial mark a significant milestone in the field of cardiac myosin inhibitors, with Aficamten demonstrating clear benefits over the standard treatment for oHCM.