WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) has announced the publication of its SEISMiC Phase 2b trial design by the European Society of Cardiology Heart Failure. The trial is exploring the safety and efficacy of istaroxime, a novel therapy aimed at addressing the challenges of cardiogenic shock—a condition characterized by high mortality and morbidity due to inadequate heart function.
Istaroxime is designed as a first-in-class treatment to enhance both systolic contraction and diastolic relaxation of the heart. Its dual mechanism aims to improve cardiac output while maintaining renal function, with a favorable safety profile. This investigational drug has shown promise in four previous Phase 2 trials involving patients with acute heart failure and early cardiogenic shock.
Dr. Steve Simonson, Chief Medical Officer at Windtree, highlighted the importance of the trial, stating, “This article reviews and explains key aspects of the Phase 2b trial including design, assessments and procedures, outcome measures and its endpoints.” He emphasized that the study’s foundation supports ongoing research, including the SEISMiC C study for more severe cases.
The trial design marks a critical step towards Phase 3 readiness, potentially offering a new therapeutic option for patients suffering from cardiogenic shock, a condition often associated with poor outcomes and limited treatment options.
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