Windtree Presents Data from its Positive SEISMiC Phase 2 Study of Istaroxime in Early Cardiogenic Shock in a Late-Breaker Presentation at the European Society of Cardiology Heart Failure Meeting in Madrid
The study met its primary endpoint of improved systolic blood pressure (SBP) profile at 6 hours
The study also met several key secondary endpoints associated with improving cardiac function
Investor conference call and webcast to be held today, Monday May 23 at 4:30 pm EDT
WARRINGTON, Pa., May 23, 2022 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular and pulmonary disorders, today presented data from its positive Phase 2 study of istaroxime in early cardiogenic shock in a late-breaker presentation at the European Society of Cardiology Heart Failure Meeting in Madrid, Spain. The study met its primary endpoint of significantly improved SBP, the critical clinical objective in treating patients with cardiogenic shock, compared to the control group at 6 hours. The significant improvement in blood pressure profile persisted through 24 hours. The study met several other secondary endpoints including assessments of cardiac function.
The SEISMiC Phase 2 study is an international, randomized, double blind, placebo-controlled study that enrolled 60 patients with Society for Cardiovascular Angiography & Interventions (SCAI) Stage B early cardiogenic shock due to severe heart failure with SBP between 75-90 mmHg. Patients were randomized on a 1:1 basis (placebo versus treatment) with two istaroxime target doses utilized in the treatment arm: (1.5 µg/kg/min in the first 13 patients and 1.0 µg/kg/min in the next 17 patients). Patients were infused for 24 hours. The primary endpoint was the difference in SBP area under the curve over six hours after initiating the infusion. Secondary endpoints included characterization of blood pressure changes over 24 hours, echocardiographic assessments of systolic and diastolic cardiac function, assessment of renal function and measures associated with safety and tolerability.
Dr. Marco Metra, principal investigator of the study and Professor of Cardiology and Director of the Institute of Cardiology of the Civil Hospital and University of Brescia, Italy, put these results into context by stating, “These data indicating istaroxime can improve both blood pressure and cardiac function are very exciting. This is the first non-adrenergic agent to potentially do so and indicate that istaroxime has the potential to become a novel approach to patient care that fills an important gap in treating patients with cardiogenic shock as well as acute heart failure and hypotension.”
Dr. Steven Simonson, Chief Medical Officer at Windtree, stated: “We are very pleased with the results demonstrated in patients experiencing early cardiogenic shock due to acute heart failure. This study provides valuable information for advancement of the istaroxime program. The positive results from SEISMiC have helped to clarify the next steps in istaroxime development, and we look forward to expanding the shock population we are studying and evaluating the benefits of istaroxime with longer infusions in our planned extension study as we progress toward a potential new therapeutic innovation for treating cardiogenic shock due to heart failure.”
Craig Fraser, CEO ofWindtree, stated, “Results from the study are consistent with and complement our prior Phase 2 data in acute heart failure. We believe istaroxime shows promise in both early cardiogenic shock and acute heart failure and could be the first drug to improve cardiac pump function without the expense of having reduced SBP or compromising renal function seen in currently available agents. We look forward to continuing our development of istaroxime and meeting with regulatory authorities and defining a potential development path to approval.”
Conference Call Details
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