Cytokinetics Announces Initiation of Phase 1 Clinical Study of CK-3772271

Cytokinetics announced that the first participants have been dosed in a Phase 1 placebo-controlled, single ascending dose clinical study of CK-3772271 (CK-271). CK-271 is a second cardiac myosin inhibitor, discovered by company scientists, in development for the potential treatment of hypertrophic cardiomyopathy (HCM).

“This Phase 1 study of CK-271 builds on our longstanding approach to advance back-up and follow-on compounds consistent with our portfolio management strategy,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “As we expand the development program for CK-274 currently in Phase 2, we plan to characterize this second cardiac myosin inhibitor to determine how it may align with our objective to develop new therapies for the potential treatment of multiple diseases associated with excessive cardiac contractility.”

Phase 1 Clinical Study Design

The primary objective of this Phase 1 placebo-controlled, single ascending dose clinical study in healthy adults is to assess the safety and tolerability of CK-271. The secondary objective is to evaluate the pharmacokinetic profile of CK-271 following single oral ascending doses. The study design includes three cohorts, with 8 adults per cohort randomized (6:2) in a blinded fashion to CK-271 or placebo. Dose escalation decisions will be made after review of the available safety, pharmacokinetic, and echocardiography data.

About CK-271

CK-3772271 (CK-271) is an allosteric cardiac myosin inhibitor that produces reversible dose- and plasma concentration-dependent reductions in cardiac contractility without affecting heart rate in preclinical models. CK-271 reduces compensatory cardiac hypertrophy and cardiac fibrosis in preclinical models of hypertrophic cardiomyopathy and heart failure with preserved ejection fraction. CK-271 is the second cardiac myosin inhibitor arising from the company’s extensive chemical optimization program conducted with careful attention to therapeutic index and pharmacokinetic properties and may be therapeutically effective by providing rapid relief of excessive hypercontractility in conditions such as HCM.

About Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is the most common inherited cardiovascular disorder, with approximately 1 in 500 individuals harboring a genetic mutation worldwide. In some, the heart muscle (myocardium) becomes abnormally thick (hypertrophied). The thickening of cardiac muscle leads to the inside of the left ventricle becoming smaller and stiffer, and thus the ventricle becomes less able to relax and fill with blood. This ultimately limits the heart’s pumping function, resulting in symptoms including chest pain, dizziness, shortness of breath, or fainting during physical activity. A subset of these patients with HCM are at high risk of progressive disease which can lead to atrial fibrillation, stroke and death due to arrhythmias. There are no current medical treatments that directly address the hypercontractility that underlies HCM.

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