Windtree Therapeutics, Inc. (WINT), a clinical-stage biotechnology company focused on advancing therapies for critical care conditions, announced it is targeting July 2025 for the interim analysis results from its SEISMiC C Phase 2 study of istaroxime in SCAI Stage C cardiogenic shock.
Istaroxime is a first-in-class dual-mechanism drug designed to improve both systolic and diastolic cardiac function, to enhance heart contractility and relaxation.
The SEISMiC C trial is a global, phase II randomized, placebo-controlled, double-blind study evaluating istaroxime when added to standard-of-care therapies (including inotropes and vasopressors) across sites in the U.S., Europe, and Latin America.
The primary endpoint is the systolic blood pressure (SBP) profile over the first six hours of treatment.
Secondary endpoints include changes in SBP at set timepoints, cardiac function measures, vasopressor-inotrope score, avoidance of shock progression, time to treatment failure, arrhythmia incidence, ICU/hospital stay duration, and 30-day outcomes.
The interim analysis will assess the first 20 patients for both efficacy signals and emerging safety data, building on previous positive Phase 2 results in SCAI Stage B cardiogenic shock.
Windtree views completion of the SEISMiC C study as a critical step toward Phase 3 development of istaroxime in cardiogenic shock, a serious complication of heart failure with limited treatment options.
Currently, WINT is trading at $0.75, down by 4.76 percent on the Nasdaq.
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