Windtree announces istaroxime Phase 2 study hit enrollment target

Windtree Therapeutics (WINT) announces that the Company has reached the planned enrollment of 20 patients for the interim analysis in its istaroxime Phase 2 SEISMiC C study in SCAI Stage C cardiogenic shock patients. The SEISMiC C Study is a global trial including sites in the U.S., Europe and Latin America. It is a placebo-controlled, double-blinded study with istaroxime being added to current standard of care, including inotropes or vasopressors. The primary endpoint of the study is the systolic blood pressure profile over the first six hours of treatment when istaroxime is used with this background therapy in more severe patients. Other key study measurements include various measures of cardiac function, SBP changes at specified timepoints, the vasopressor-inotrope score, avoidance of progression to more severe shock in addition to other clinical assessments. The interim analysis will be primarily looking at preliminary safety and tolerability in this setting and an assessment of preliminary efficacy signals to appropriately size the remainder of the SEISMiC C trial. A statistically significant efficacy signal is not anticipated at the interim analysis.