Cytokinetics Announces Start of Redwood-HCM, a Phase 2 Clinical Trial of CK-3773274

Next-Generation Cardiac Myosin Inhibitor Advances In Clinical Trial Designed to Assess Effects Using Two-Week Dose Titration Schedule

SOUTH SAN FRANCISCO, Calif., Jan. 06, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM) has opened to enrollment. REDWOOD-HCM is a Phase 2 clinical trial of CK-3773274 (CK-274), a next-generation cardiac myosin inhibitor discovered by company scientists, which Cytokinetics is developing for the potential treatment of hypertrophic cardiomyopathy (HCM).

“Our ability to quickly begin REDWOOD-HCM following the recently announced and encouraging Phase 1 data is a result of the enthusiasm of our clinical trial sites and participating investigators working in partnership with our dedicated team here at our company,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “Our Phase 1 study showed CK-274 achieved the intended pharmacodynamic effect and exposure-response relationship reaching steady state pharmacokinetics levels within 14 days, thereby enabling a dose titration regimen at two-week intervals.  REDWOOD-HCM is designed to evaluate translation of a flexible dose optimization schedule with CK-274 to therapeutic window and echocardiographic parameters associated with clinical outcomes in patients with HCM.”

“Patients suffering from HCM experience daily limiting symptoms that significantly decrease their overall quality of life.   What they may benefit from is an alternative therapy designed to optimally treat the underlying cause of their disease,” said Marty Maron, M.D., Director, Hypertrophic Cardiomyopathy Center; Director, Cardiac CT and MRI; Tufts University School of Medicine, and Principal Investigator of REDWOOD-HCM. “Investigating CK-274 in this Phase 2 trial is an important step toward a potential new treatment option for HCM patients.”

REDWOOD-HCM: Clinical Trial Design

REDWOOD-HCM is a multi-center, randomized, placebo-controlled, double-blind, dose-finding clinical trial in patients with symptomatic, obstructive HCM (oHCM). The primary objective of the trial is to determine the safety and tolerability of CK-274. The secondary objectives are to describe the concentration-response and dose-response relationship of CK-274 on the resting and post-Valsalva left ventricular outflow tract gradient as measured by echocardiography during 10 weeks of treatment. Additionally, the trial will evaluate the plasma concentrations of CK-274 in patients with oHCM in relationship to dose. Exploratory objectives include the effect of CK-274 on N‑terminal prohormone of brain natriuretic peptide (NT‑proBNP) and New York Heart Association (NYHA) Functional Classification.