April 13, 2007 — Cytokinetics Inc. announced yesterday the initiation of Phase II clinical trials program evaluating CK-1827452, a novel cardiac myosin activator for the potential treatment of patients with either acutely decompensated or chronic heart failure.
The first patient has been dosed in the first Phase IIa clinical trial, which is designed to evaluate the safety, tolerability, pharmacodynamic and pharmacokinetic profile of an intravenous formulation of CK-1827452 in patients with stable heart
failure. CK-1827452 is the subject of a Collaboration and Option Agreement recently executed by Cytokinetics with Amgen Inc.
This first Phase II clinical trial, now underway in the United Kingdom, is a multicenter, double-blind, randomized, placebo-controlled, dose-escalation, pharmacokinetic and pharmacodynamic study of CK-1827452 in patients with stable heart failure.
The primary objective of this trial is to evaluate the safety and tolerability of CK-1827452 administered as an intravenous infusion to stable heart failure patients. The secondary objectives of this trial are to establish a relationship between plasma concentration and pharmacodynamic effect for CK-1827452 and to determine the pharmacokinetics of CK-1827452 in stable heart failure patients.
In addition to routine assessments of vital signs, blood samples and ECG monitoring, echocardiograms will be performed to evaluate cardiac function at various pre-defined time points.