Cytokinetics provide update on cardiac myosin inhibitor programs at Analyst Day

Cytokinetics 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 and highlight commercial readiness activities in advance of the potential approval and launch of aficamten. New Long-Term Data from FOREST-HCM Support Development Program for Aficamten: The company plans to present 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, 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 less than50%. During the maintenance phase, there have been no instances of LVEF less than40%, which would require dose interruption, and only three instances of LVEF less than50% that required a dose down-titration. Therefore, of the 579 monitoring echocardiograms completed during the maintenance phase of treatment, 99.5% of them did not result in a dose reduction. Additionally, after prolonged treatment for more than two years in some patients, the mean resting left ventricular outflow tract gradients and mean Valsalva LVOT-Gs remained reduced and below the diagnostic threshold for obstructive HCM. Patients also experienced sustained reductions in cardiac biomarkers and improved symptoms. Preparing for Commercial Readiness for the Potential Approval and Launch of Aficamten: Cytokinetics commercial leaders will provide an update on the company’s commercial readiness activities, including results of market research and customer segmentation exercises which inform positioning, branding, payer access and sales strategies. The company has structured its current commercial planning initiatives with a focus to gaining a deep understanding of the HCM market and designing an optimal physician and patient experience. Expanding Clinical Research with CK-586 for the Potential Treatment of HFpEF: The company plans to present today new pre-clinical data for CK-586, a cardiac myosin inhibitor, which is currently the subject of an ongoing Phase 1 study and is in development for the potential treatment of patients with HFpEF. These preclinical data show improved diastolic function and reduced cardiac fibrosis in an animal model of HFpEF.