September 27, 2022 — Windtree Therapeutics, Inc., a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular disorders, 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.
About Cardiogenic Shock
Cardiogenic shock is a serious condition that occurs when the heart is failing significantly and cannot pump enough blood and oxygen to the brain, kidneys, and other vital organs. Mortality rates are significant and, depending on severity, range from 7% to 40% in the U.S. There is a lack of satisfactory pharmacological intervention to reverse the condition as available therapies have unwanted side effects such as risk for arrhythmias, decreasing blood pressure, renal dysfunction and even increases in mortality that limit their usefulness and position them as “rescue medicines” for severe cases. Market research revealed 99% of 100 U.S.-based clinical cardiologists interviewed who treat cardiogenic shock patients responded that new drug innovation to treat SCAI class B cardiogenic shock patients is highly needed. The cardiogenic shock worldwide total market value is estimated to be $1.25 billion, calculated by using cardiogenic shock patient US hospital claims and worldwide prevalence data multiplied by assumed various regional prices of drug treatment.
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