New Long-Term Data from FOREST-HCM, the Open-Label Extension Study of Aficamten,Show Sustained Improvements in Clinical Efficacy Endpointsand No Treatment Interruptions for Low Ejection Fraction
Commercial Readiness Activities Leverage Insights from Market Research to Inform Market Segmentation and Patient-Centric Strategies
New Pre-Clinical Data for CK-586 Shows Improved Diastolic Function and Reduced Cardiac Fibrosis in Animal Model of HFpEF; Phase 1 Study Ongoing
SOUTH SAN FRANCISCO, Calif., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) will provide an update on the company’s cardiac myosin inhibitor programs and plans to build a specialty cardiology franchise today at its virtual Investor and Analyst Day, “New Horizons in Hypercontractility.” The company plans to review the broad development program for aficamten and present new long-term data from FOREST-HCM (Follow-up, Open-Label, Research Evaluation of Sustained Treatment with Aficamten in HCM) and highlight commercial readiness activities in advance of the potential approval and launch of aficamten. The company will also present new preclinical data for CK-4021586 (CK-586), a cardiac myosin inhibitor in development for the potential treatment of patients with heart failure with preserved ejection fraction (HFpEF). Today’s event will also feature perspectives from leading physician experts and a patient advocate living with hypertrophic cardiomyopathy (HCM).
“Cytokinetics is advancing plans to build a specialty cardiology franchise anchored by aficamten. We believe we have a unique opportunity to address the multiple manifestations of cardiac hypercontractility with both our late-stage programs and our earlier-stage pipeline,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We expect that, if aficamten is approved, our investment in its clinical development program will support the potential to build a foundation rooted in obstructive HCM, expand into non-obstructive HCM, and bridge to HFpEF while also pursuing opportunities in advanced heart failure. We are uniquely positioned to pursue a specialty cardiology franchise and deliver on the promise of our science to bring forward new medicines for patients given the combination of our pioneering leadership in muscle biology, focused cardiology expertise and strong relationships with institutions, cardiologists and payers.”
New Long-Term Data from FOREST-HCM Support Development Program for Aficamten
The company plans to present today new long-term efficacy and safety data from FOREST-HCM, an open-label extension clinical study of aficamten. More than 200 patients have been enrolled in FOREST-HCM to date and 143 patients were available for this analysis. Of the 94 patients who had completed the titration period (by Week 12), approximately two-thirds are receiving the 15 mg or 20 mg doses of aficamten. During the titration period, there have been no treatment-related instances of left ventricular ejection fraction (LVEF)