Windtree says interim results for SEISMiC SCAI Stage C study set for July 2025

Windtree Therapeutics (WINT) announced it is targeting the planned interim analysis results for the istaroxime cardiogenic shock SEISMiC SCAI Stage C Phase 2 study for July 2025. 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 effect of istaroxime in addition to these therapies will be assessed for six hours followed by the ability for istaroxime to allow reduction in the other inotropes and vasopressors based on the patient’s condition. The primary endpoint of the study is the systolic blood pressure profile over the first six hours of treatment. Other key study measurements include various measures of cardiac function, SBP changes at specified timepoints, the vasopressor-inotrope score, avoidance of progression to SCAI Stage D or E cardiogenic shock and need for mechanical cardiac support, time to treatment failure, arrhythmia assessments, days alive and out of the hospital through day 30, physiologic measures and length of stay in the intensive care unit and hospital.