WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) has announced the successful completion of patient enrollment in its SEISMiC Extension Phase 2b study. This research focuses on istaroxime, a promising therapy for early cardiogenic shock caused by heart failure. The study aims to assess istaroxime’s ability to enhance heart function and stabilize blood pressure, building upon previous positive outcomes from earlier Phase 2 trials.
Istaroxime is a novel treatment that has shown potential in improving the heart’s contraction and relaxation while boosting blood pressure without increasing the risk of cardiac arrhythmias. This makes it a significant candidate for addressing cardiogenic shock, a critical condition occurring when the heart fails to supply enough blood to vital organs, leading to high mortality rates.
The SEISMiC Extension Study spans the U.S., Europe, and Latin America, focusing on dose optimization and the therapeutic potential of istaroxime’s novel SERCA2a mechanism. It involves patients with early-stage cardiogenic shock, exploring two dosing regimens: a tapering dose and a constant dose over up to 60 hours.
Steve Simonson, MD, Chief Medical Officer of Windtree, stated, “Completing enrollment in the SEISMiC Extension Study is an important step in advancing the istaroxime program to Phase 3, along with the ongoing SEISMiC C study in more severe cardiogenic shock patients. We look forward to announcing topline results from the SEISMiC Extension Study by the end of the month.”
The study hopes to confirm istaroxime’s benefits, potentially offering a new treatment path for patients with limited options, and paving the way for larger-scale clinical trials.
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