On Wednesday, Windtree Therapeutics, Inc. WINT released topline results from its Phase 2b SEISMiC Extension Study of istaroxime for patients in early cardiogenic shock due to heart failure.
The study is focused on the effects of istaroxime on blood pressure, cardiac function, and other parameters over 96 hours of close monitoring, with the final visit at 30 days.
The study met its primary endpoint by significantly improving systolic blood pressure over six hours, with the combined istaroxime group performing significantly better than the placebo group.
Systolic blood pressure is the pressure in arteries when the heart contracts and pumps blood.
Significant benefits were also seen in many secondary endpoints.
The safety profile was favorable and generally consistent with what has been previously reported in other clinical trials.
Further details of study results, including other measures of efficacy and safety and by individual istaroxime dosing groups, are planned to be presented at the Heart Failure Society of America Meeting on September 30.
Craig Fraser, Chairman and CEO of Windtree, stated, “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. We are excited to share the details of study results next week and to continuing to progress istaroxime towards Phase 3 readiness for cardiogenic shock.”
Price Action: WINT stock is down 7.98% at $3 during the premarket session at the last check on Wednesday.
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