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Cytokinetics Announces Data From Phase 1 Study of CK-3773274 at the HFSA 23ʳᵈ Annual Scientific Meeting
Pharmacokinetic/Pharmacodynamic Relationship in Humans Similar to Preclinical Findings Planned Phase 2 Clinical Trial Design Data Support Progression to Phase
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"Pharmacokinetic/Pharmacodynamic Relationship in Humans Similar to Preclinical Findings \n\n \n \n \n \n \n \n \n \n \n \n \n Planned Phase 2 Clinical Trial Design\n \n \n \n \n \n \n \n \n\n Data Support Progression to Phase 2 Clinical Trial in Patients with Obstructive Hypertrophic Cardiomyopathy to Begin in Q4 2019 SOUTH SAN FRANCISCO, Calif., Sept. 16, 2019 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced data from the Phase 1 study of CK-3773274 (CK-274) were presented in a poster session at the HFSA 23rd Annual Scientific Meeting in Philadelphia. The study met its primary and secondary objectives to assess the safety and tolerability of single and multiple oral doses of CK-274, describe the pharmacokinetics (PK) of CK-274 and its pharmacodynamic effects (PD) as measured by echocardiography, as well as to characterize the PK/PD relationship with regards to cardiac function. These data support the advancement of CK-274 into a Phase 2 clinical trial in patients with obstructive hypertrophic cardiomyopathy which is expected to begin in Q4 2019. CK-274 is a novel selective cardiac myosin inhibitor, discovered by company scientists, in development for the potential treatment of hypertrophic cardiomyopathy (HCM). Phase 1 Design and Key Findings The primary objective of this Phase 1 double-blind, randomized, placebo-controlled, multi-part, single and multiple ascending dose study was to assess the safety and tolerability of CK-274 in healthy volunteers. The study design included single ascending dose cohorts and multiple ascending dose cohorts, with eight healthy subjects per cohort. Additional objectives included to describe the PK of CK-274 and its PD effects as measured by echocardiography, as well as to characterize the relationship between the two with regards to cardiac function. This study was not designed to identify a maximum tolerated dose of CK-274. The study demonstrated that CK-274 was safe and well tolerated in healthy participants. No serious adverse events and no clinically meaningful changes in vital signs, ECGs or laboratory tests were observed. Stopping criteria for continued dose escalation were reached after a single dose of 75 mg and after 14 days of a daily of 10 mg dose. Decreases in ejection fraction below 50% were readily reversible within six hours following single doses and w...