WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) has announced encouraging topline results from its Phase 2b SEISMiC Extension Study investigating istaroxime in patients experiencing early cardiogenic shock due to heart failure. This condition, characterized by low blood pressure and inadequate blood flow, poses a significant risk of morbidity and mortality.
Istaroxime, a novel first-in-class investigational therapy, is designed to enhance heart function by improving systolic contraction and diastolic relaxation, while increasing blood pressure and preserving renal function. The SEISMiC study, conducted across the United States, Europe, and Latin America, evaluated the effects of istaroxime on 30 subjects, focusing on its ability to correct low blood pressure and enhance cardiac function over a 96-hour monitoring period.
The study successfully met its primary endpoint, showing a significant improvement in systolic blood pressure compared to placebo. This was achieved even with the extended dosing duration of up to 60 hours, suggesting a promising potential for improving treatment outcomes beyond previous 24-hour regimens.
Key findings from the study include a 15% improvement in cardiac output and significant reductions in heart rate and pulmonary capillary wedge pressure, an indicator of cardiac filling pressure. Additionally, renal function showed improvement, and adverse events were generally consistent with previous trials, highlighting istaroxime’s favorable safety profile.
Professor Alexandre Mebazaa, a critical care and heart failure expert, noted, “Istaroxime has a unique profile. It may be the only drug candidate that has been shown to simultaneously improve blood pressure, cardiac output, and renal function without increasing heart rate or risk for cardiac arrhythmias.”
Craig Fraser, CEO and Chairman of Windtree Therapeutics, expressed optimism about the study’s results, stating, “We are very pleased with the results of this SEISMiC cardiogenic shock study… We are excited to pursue the next steps of development to potentially deliver an important therapy for patients that need better treatments for this critical condition.”
The company plans to continue its development efforts, aiming to bring this promising therapy to patients in need of improved treatment options for heart failure and cardiogenic shock.
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