Windtree Therapeutics Announces Istaroxime Cardiogenic Shock SCAI Stage C Phase 2 Study Planned Interim Analysis Results Targeted for July 2025

Istaroxime has previously completed two positive Phase 2 studies in SCAI Stage B cardiogenic shock; the SEISMiC C study in SCAI Stage C cardiogenic shock is another step progressing to the istaroxime cardiogenic shock Phase 3 program

Excerpt from the Press Release:

WARRINGTON, Pa., May 22, 2025 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue-generating company and advancing early and late-stage innovative therapies for critical conditions and diseases, today announced it is targeting the planned interim analysis results for the istaroxime cardiogenic shock SEISMiC SCAI Stage C Phase 2 study (the “SEISMiC C 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 (“SBP”) 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 (e.g., cardiac index) and length of stay in the intensive care unit and hospital.

“The interim data from the SEISMiC C Study are very important as we continue to evaluate the profile of istaroxime in more seriously ill patients with cardiogenic shock due to heart failure. The data from the first 20 patients will provide an initial assessment of the ability of istaroxime to show the same kind of physiological impact on top of standard of care to what has been seen in the previous studies in SCAI Stage B cardiogenic shock, as well as the emerging safety profile in this population,” said Dr. Steve Simonson, Chief Medical Officer and Senior Vice President of Windtree Therapeutics.

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