Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM

Launched by CYTOKINETICS · Apr 13, 2021

Keywords

ClinConnect Summary

This is an open-label extension study called FOREST-HCM, designed to collect long-term safety and tolerability data on aficamten for adults with hypertrophic cardiomyopathy (HCM). It plans to enroll up to about 900 adults aged 18–85 who have symptomatic HCM and a normal heart pumping function at screening (LVEF 55% or higher). To join, you must have already completed a previous Cytokinetics trial of aficamten and not recently used mavacamten or participated in another investigational study. Certain heart conditions and recent heart procedures (like septal reduction or an implanted heart device within a month) may disqualify someone from joining.

Participants will take aficamten by mouth every day, starting at a low dose and increasing to the highest dose you can tolerate (up to 20 mg). During the first part of the study, visits happen roughly every 2–6 weeks to adjust the dose; after that, visits are about every 24 weeks, with safety checks by phone about every 12 weeks. The study will watch for safety signals such as adverse events and changes in heart function (including how well the heart pumps and, in some people with obstructive HCM, measures of blood flow blockage). The trial is international and run by Cytokinetics, and results are not yet available since the study is ongoing with follow-up lasting up to about 5 years.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Completion of a Cytokinetics trial investigating aficamten
• • LVEF ≥ 55% at the Screening Visit
• Exclusion Criteria:
• • Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.
• • Has participated in another investigational device or drug study or received an investigational device or drug \< 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.
• * Since completion of a previous trial of aficamten has:
• • Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) \< 30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) \< 100 bpm and/or rhythm is stable \> 30 days
• • Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation)
• • Had a confirmed LVEF \< 40% with an associated dose interruption during participation in a prior study with aficamten
• • History of implantable ICD placement within 30 days prior to screening.