WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) has reported encouraging interim results from its ongoing SEISMiC C Phase 2 trial evaluating istaroxime in patients with SCAI Stage C cardiogenic shock, signaling momentum toward a global Phase 3 program.
The interim analysis included data from the first 20 patients enrolled in the randomized, placebo-controlled study. Istaroxime, administered alongside standard therapies such as inotropes and vasopressors, demonstrated a favorable safety profile, with no new concerns identified. Importantly, improvements in hemodynamic and echocardiographic measures were consistent with earlier findings from previous trials.
The SEISMiC C trial builds on data from SEISMiC B, where istaroxime was shown to improve key cardiovascular indicators in patients with milder forms of cardiogenic shock. In contrast, SEISMiC C targets patients with more advanced disease, offering insights into how istaroxime performs when added to existing treatment regimens in severe cases.
Cardiogenic shock, particularly at SCAI Stage C, presents as critically low blood pressure accompanied by signs of organ failure. This condition often requires the use of vasopressors or inotropes in intensive care units, but treatment options remain limited.
Windtree’s investigational drug, istaroxime, is a dual-mechanism agent designed to enhance both the contraction and relaxation phases of the heart cycle. It works by inhibiting the Na+/K+ ATPase pump to improve systolic function and activating the SERCA2a calcium pump to support diastolic recovery. Unlike traditional inotropes, it has shown the ability to enhance cardiac output and blood pressure without increasing heart rate or triggering arrhythmias.
The SEISMiC C trial includes study sites across the U.S., Europe, and Latin America and is considered a key step in Windtree’s broader strategy to address acute decompensated heart failure across a range of severity levels.
Company executives say the latest results reinforce their confidence in advancing istaroxime into a global Phase 3 trial, with the goal of establishing a new therapeutic standard for cardiogenic shock.
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