WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) this week reported that a late-breaking abstract describing dose-response data from its positive Phase 2 clinical study of istaroxime in early cardiogenic shock (SEISMiC) will be presented on October 2 at the Heart Failure Society of America Annual Scientific Meeting in Washington, DC.
“The SEISMiC study in SCAI Stage B early cardiogenic shock indicates that istaroxime has the potential to be an innovative therapy that can rapidly improve cardiac function and blood pressure in patients with severe heart failure and do so with an acceptable tolerability profile,” said Dr. Steven Simonson, Chief Medical Officer of Windtree. “The late-breaker abstract at the Heart Failure Society of America meeting will elaborate on istaroxime dose effects in the SEISMiC study, which is helping to inform our istaroxime clinical development strategy with ongoing work in the clinic and planned meetings with regulatory authorities to progress towards a Phase 3 program in cardiogenic shock.”
The SEISMiC study met its primary endpoint of significantly improved systolic blood pressure over the first 6 hours of study drug infusion. This is an important clinical objective in treating patients with cardiogenic shock. The significant improvement in blood pressure profile persisted through 24 hours. Patients treated with istaroxime experienced a substantial increase in stroke volume (the amount of blood pumped from the heart with each contraction) that contributed to an increased cardiac output without increasing heart rate. The study met several other secondary endpoint assessments of cardiac function. Importantly, renal function was not worsened with istaroxime infusion.
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