The safety data from this interim analysis suggest that the drug was well-tolerated with no serious adverse events reported in heart failure patients exposed to the intended range of plasma concentrations. In addition, data from the first two cohorts demonstrated that, when compared to placebo, CK-1827452 produced statistically significant and clinically relevant increases in Doppler-derived stroke volume and fractional shortening in association with statistically significant prolongations of systolic ejection time.
Statistically significant correlations were observed between the increases in each of these three indices of cardiac ventricular function and increases in the plasma concentration of CK-1827452. Heart rate and blood pressure remained unchanged in the first two cohorts of the Phase IIa trial.
Following review of data from this interim analysis, Cytokinetics initiated treatment in the third cohort of this trial. In this cohort, stable heart failure patients are planned to undergo four treatment periods, receiving three escalating active doses of CK-1827452 and one placebo treatment randomized into the dose escalation sequence. Infusions will be 24 hours in duration and are intended to target plasma concentrations within the range evaluated in the first two cohorts.
Andrew Wolff, chief medical officer of Cytokinetics, said: “These first results in stable heart failure patients support the important role that CK-1827452 may have in the treatment of heart failure.”