WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) has reported promising outcomes from its Phase 2b SEISMiC Extension Study, showcasing the potential of istaroxime in managing early cardiogenic shock caused by heart failure. This condition, characterized by low blood pressure and impaired heart function, necessitates urgent treatment options, and istaroxime’s introduction could be pivotal.
The SEISMiC Extension Study was conducted in the U.S., Europe, and Latin America, targeting patients with SCAI Stage B cardiogenic shock. A core aim was to improve systolic blood pressure over a six-hour period, a crucial factor in treating cardiogenic shock. Participants were treated with either a decreasing or constant dose of istaroxime or given a placebo. The results demonstrated that the istaroxime groups significantly enhanced systolic blood pressure compared to the placebo group, successfully meeting the primary endpoint. Additionally, secondary endpoints indicated benefits for heart and renal function, without increasing cardiac arrhythmias, a common issue with current medications.
Dr. Steve Simonson, Senior Vice President and Chief Medical Officer at Windtree, highlighted the study’s success: “We are very pleased with the results of the study and the potential for istaroxime to positively impact patients in acute heart failure with early cardiogenic shock.” The findings underline the drug’s potential as a safer alternative with fewer cardiac complications.
Craig Fraser, Chairman and CEO of Windtree, emphasized the need for innovative treatments in this area, stating, “Cardiogenic shock is a critical condition with high morbidity and mortality where clinicians note a high need for new drug innovation. Across four Phase 2 studies to date, istaroxime has demonstrated a highly unique and attractive profile as a potential therapy for cardiogenic shock and acute heart failure patients.”
Windtree Therapeutics plans to present further details at the Heart Failure Society of America Meeting on September 30, 2024. Following the conference, a press release and an investor call will provide more comprehensive insights into the study’s findings. With these results, istaroxime is positioned as a promising candidate for further development, offering hope for improved management of early cardiogenic shock.
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