The first patient has been dosed in the first phase IIa trial, which is designed to evaluate the safety, tolerability, pharmacodynamic and pharmacokinetic profile of an intravenous formulation of the treatment CK-1827452 in patients with stable heart failure. CK-1827452 is the subject of a collaboration recently executed by Cytokinetics with Amgen.
The primary objective of this trial is to evaluate the safety and tolerability of CK-1827452 administered as an intravenous infusion. 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.
This first phase II clinical trial for CK-1827452 is part of a clinical trials program, to be conducted by Cytokinetics, which is planned to be comprised of phase I and phase II trials designed to evaluate CK-1827452 in a diversity of patients, including those with stable heart failure, ischemic heart disease, impaired renal function and acutely decompensated heart failure, and patients with chronic heart failure at increased risk for death and hospital admission for heart failure. These trials are planned to evaluate CK-1827452 in both intravenous and oral formulations.
In January 2007, Cytokinetics and Amgen announced a strategic collaboration to discover, develop and commercialize novel small-molecule therapeutics that activate cardiac muscle contractility for potential applications in the treatment of heart failure.
According to industry reports, the US market for heart failure drugs was approximately $1.3 billion in 2004.