WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) has announced its plan to release interim data from the SEISMiC SCAI Stage C Phase 2 study (SEISMiC C Study) by July 2025. This global trial evaluates the potential of istaroxime, a first-in-class dual-mechanism therapy, in treating patients suffering from cardiogenic shock due to heart failure.
The SEISMiC C Study involves a placebo-controlled, double-blinded methodology, assessing the effects of istaroxime alongside the standard of care, including inotropes or vasopressors. The primary endpoint is the systolic blood pressure (SBP) profile over the initial six hours of treatment, with secondary measurements such as cardiac function, vasopressor-inotrope scores, and patient outcomes over 30 days.
“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,” said Dr. Steve Simonson, Chief Medical Officer and Senior Vice President at Windtree. He emphasized that the analysis of the first 20 patients will provide a critical assessment of istaroxime’s efficacy and safety in addressing the needs of this vulnerable population.
Istaroxime operates through a dual mechanism that improves both systolic and diastolic cardiac function, uniquely increasing myocardial contractility while enhancing myocardial relaxation. Multiple Phase 2 studies in earlier-stage cardiogenic shock have shown significant improvements in cardiac function and blood pressure without elevating heart rate or inducing significant rhythm disturbances.
Windtree regards the SEISMiC C Study as a critical step forward in advancing to Phase 3 trials. The results are expected to offer valuable insights into istaroxime’s capacity to enhance patients’ outcomes and set a pathway for its development as a novel solution for cardiogenic shock management.
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