Clinical Data
Study ITI-214-104 was a randomized, double-blind, placebo-controlled study of escalating single oral doses of ITI-214 (10, 30, and 90 mg) in patients with HFrEF NYHA class II-III. The primary objective of the study was to determine the effects of ITI-214 on cardiac function, using echocardiography with Doppler imaging, in patients with reduced ejection fraction (≤35%) who were already maintained on standard-of-care treatment. Safety was evaluated by monitoring for hemodynamic effects and changes in cardiac rhythm.Thirty-five patients were enrolled in this study, 9 in each of three dose cohorts and 8 in the placebo arm. The mean age of the patients was 54; 57% were male, and 57% were black. The etiology of the heart failure was ischemic heart disease in 31% of the patients. The mean left ventricular ejection fraction at screening was 25%. In this study, compared to placebo, single doses of ITI-214 increased mean left ventricular (LV) power index and cardiac output while systemic vascular resistance and mean arterial blood pressure decreased. Reported adverse events were all mild to moderate and consisted of three occurrences of orthostatic hypotension and three episodes of non-postural hypotension. Patients were monitored by continuous telemetry, and no changes in heart rhythms were noted. No serious adverse events were reported. Further details of these results will be presented at upcoming medical conferences.