Istaroxime was added to currently available inotropes and vasopressors in the study - no new safety signals were identified and physiological improvements were consistent with istaroxime responses in previous trials The SEISMiC C Study is a global trial including sites in the U.S., Europe and Latin America. It is placebo- controlled, double-blinded study with istaroxime being added to current standard of care, including inotropes or vasopressors in patients with more severe cardiogenic shock (SCAI stage C) ...

Core Insights - The SEISMiC C Study is the third study in the istaroxime cardiogenic shock development program, focusing on SCAI Stage C patients who are more severely ill [1][2] - Windtree Therapeutics has reached the planned enrollment of 20 patients for the interim analysis in the SEISMiC C study [1][3] - The study is a global, placebo-controlled, double-blinded trial assessing the safety and preliminary efficacy of istaroxime in combination with standard care [2][3] Study Design and Objectives - The primary endpoint is the systolic blood pressure profile over the first six hours of treatment, with additional measurements including cardiac function and vasopressor-inotrope score [2] - The interim analysis will focus on preliminary safety and tolerability, with no statistically significant efficacy signal expected at this stage [2] Company Strategy and Future Plans - The SCAI Stage C study is considered valuable for Phase 3 readiness of istaroxime, targeting an important patient population for future studies [3] - The company aims to differentiate istaroxime from currently available treatments and is progressing towards bringing the drug candidate to market [3] Product Information - Istaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function, showing promise in previous Phase 2 studies [4] - The drug acts as a positive inotropic agent, enhancing myocardial contractility and facilitating myocardial relaxation [4] Company Overview - Windtree Therapeutics, Inc. is focused on becoming a revenue-generating company across multiple growing industries [5]