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Windtree Announces Publication of Istaroxime Positive Phase 2 SEISMiC B Study
Globenewswire· 2025-06-16 12:00
Core Insights - The Phase 2 Istaroxime study demonstrated success across multiple endpoints, indicating potential for approval in targeted indications [1][3] - The primary endpoint of increasing systolic blood pressure was met, with additional benefits such as no increase in heart rate and preserved renal function [1][3] - Discussions are ongoing with multiple potential partners to fund the remaining clinical development, which could alleviate the company's cash burn in the cardiovascular pipeline [1][5] Company Developments - Windtree Therapeutics is nearing completion of the protocol design for a Phase 3 study in acute heart failure for a regional license partner, which will be fully funded by the licensee [2] - The early cardiogenic shock Phase 2 study, SEISMiC B, has been published, highlighting the safety and efficacy of intravenous Istaroxime for patients with pre-cardiogenic shock [2][4] - The cardiogenic shock market was valued at $1.25 billion in 2020, indicating significant market potential for Istaroxime [5] Clinical Study Results - Istaroxime significantly increased blood pressure within the first six hours of treatment, with effects persisting for 60 hours, and improved cardiac output without increasing heart rate or causing significant arrhythmias [3][7] - The drug has completed four positive Phase 2 studies, including two focused on early cardiogenic shock, showcasing a strong profile for potential innovation in treatment [4][5] - The upcoming SEISMiC C trial will assess more severe SCAI Stage C cardiogenic shock patients, aiming to complete the evaluation for the intended Phase 3 patient population [5]