After successful SEISMiC A and B studies in Early Cardiogenic Shock, SEISMiC C will treat more severe SCAI Stage C cardiogenic shock to complete the assessment of the intended Phase 3 patient population
Windtree plans to engage with regulatory authorities in 2025 for Transition to Phase 3 clinical trial
WARRINGTON, Pa., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. ("Windtree" or the "Company") (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced the initiation of enrollment in the SEISMiC C trial in SCAI Stage C cardiogenic shock. This study follows the positive results in both SEISMiC A and B in SCAI Stage B cardiogenic shock trials. In these trials, istaroxime improved systolic blood pressure, cardiac function and renal function without an increased risk for cardiac arrhythmias, a profile that differentiates istaroxime from currently used medications to treat shock. SCAI Stage C cardiogenic shock is a more severely ill population than was previously studied with istaroxime. SCAI Stage C patients have progressed in their cardiogenic shock and heart failure to the point of tissue and vital organ hypoperfusion (lack of blood flow and oxygen) and typically require inotropic or vasopressor drugs for support. These drugs are used with caution due to deleterious side effects – many of which we believe istaroxime may potentially avoid based on results to date from four previous studies in acute heart failure and early cardiogenic shock. The Company intends to include SCAI Stage C patients as part of the Phase 3 patient population for cardiogenic shock.
