WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) announced that interim Phase 2 trial data for its investigational therapy istaroxime will be presented at the Heart Failure Society of America’s 2025 Annual Scientific Meeting. The study focuses on patients with SCAI Stage C cardiogenic shock, a severe complication of heart failure with an in-hospital mortality rate of 20–30%.
The presentation will highlight results from the SEISMiC C trial, which evaluated a 48-hour intravenous infusion of istaroxime in patients with cardiogenic shock. Interim findings from the first 20 patients showed no new safety concerns and no increase in clinically significant arrhythmias when used alongside standard care. Hemodynamic and echocardiographic improvements were consistent with prior istaroxime studies.
Istaroxime, a first-in-class dual-mechanism therapy, is designed to enhance both systolic and diastolic heart function. It increases myocardial contractility by inhibiting Na+/K+-ATPase while also promoting myocardial relaxation through activation of the SERCA2a calcium pump, improving calcium reuptake in heart muscle cells. Previous studies have demonstrated that istaroxime can raise blood pressure and improve cardiac performance without elevating heart rate or causing significant rhythm disturbances.
Acute decompensated heart failure and cardiogenic shock have seen little pharmaceutical innovation in decades, and Windtree believes istaroxime could address a major unmet need. “We are very pleased with the interim results of the SEISMiC C study,” said Windtree CEO Jed Latkin. “We believe istaroxime can be an important drug innovation for acute decompensated heart failure and cardiogenic shock patients because the istaroxime studies have promising results and this is a condition with a large unmet need and has been underserved for decades.”
Based on the encouraging safety and efficacy profile, Windtree plans to advance istaroxime into a global Phase 3 study for cardiogenic shock in the second half of 2025.
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