WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) has announced the publication of findings from its Phase 2 SEISMiC B study on istaroxime in the Journal of Heart and Lung Transplantation. This trial adds to the growing evidence supporting istaroxime’s potential as an innovative treatment for early cardiogenic shock, a condition marked by poor cardiac function and low blood pressure requiring urgent intervention.
The study demonstrated that istaroxime significantly increased systolic blood pressure during the first six hours of treatment, with improvements sustained for 60 hours. Other benefits included enhanced cardiac output, reduced pulmonary capillary wedge pressure, and preserved renal function. Importantly, the treatment showed no increase in heart rate or significant cardiac arrhythmias, establishing a strong safety and efficacy profile for the drug.
Supporting the study findings, an accompanying editorial described istaroxime as a “potential new approach to heart failure-cardiogenic shock in which the next frontier is not just survival, but earlier and smarter stabilization.”
Jed Latkin, CEO of Windtree Therapeutics, emphasized the potential impact of the treatment, stating, “We are having discussions with multiple potential partners for our cardiovascular pipeline. Removing this clinical development cash burn would be valuable to the company. Additionally, the cardiogenic shock market value was $1.25 billion in 2020, and we believe istaroxime has a unique profile that can provide needed innovation for patients.”
Istaroxime has already completed four Phase 2 studies, including two in early cardiogenic shock, establishing it as a promising candidate for future treatment protocols. The ongoing SEISMiC C study will focus on more severe stages of cardiogenic shock to better define the intended Phase 3 patient population.
Steve Simonson, Windtree’s Chief Medical Officer, highlighted the drug’s progress and potential advantages over traditional treatments. “Istaroxime is demonstrating a unique profile that the company believes is differentiating from currently available drug treatments,” he said. “We are excited about the profile of istaroxime and how it may improve the care for patients with acute heart failure and cardiogenic shock.”
Istaroxime’s mechanisms of action offer a dual benefit, improving systolic and diastolic cardiac function while minimizing side effects commonly associated with current therapies. As the company moves closer to initiating Phase 3 trials, Windtree remains committed to addressing a critical unmet need in cardiogenic shock and heart failure therapy.
With the publication of the SEISMiC B study and the forthcoming SEISMiC C results, istaroxime is advancing as a key player in the effort to improve outcomes for patients facing severe cardiovascular conditions.
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