WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) has achieved a major milestone in its Phase 2 SEISMiC C study, announcing the planned enrollment of 20 patients for its interim analysis. This study focuses on evaluating the safety and preliminary efficacy of istaroxime in treating patients with SCAI Stage C cardiogenic shock, a severe condition with limited effective treatment options and high mortality rates.
The ongoing global, placebo-controlled, double-blinded trial is evaluating istaroxime as an addition to standard therapies like inotropes and vasopressors, targeting improvements in systolic blood pressure (SBP) over the first six hours of treatment. The interim analysis will examine safety, tolerability, and initial efficacy signals to guide the remaining design of the SEISMiC C trial.
The SEISMiC C study marks the third Phase 2 study in Windtree’s istaroxime cardiogenic shock development program, extending the evaluation into a more critically ill patient population compared to earlier trials in SCAI Stage B patients. The results are expected to support Phase 3 readiness and inform discussions with the FDA at the end of Phase 2.
“We are pleased to reach the study enrollment needed for the interim analysis in SCAI Stage C patients with cardiogenic shock,” said Steve Simonson, M.D., Chief Medical Officer of Windtree. “As we make progress toward Phase 3 readiness for istaroxime, we believe the profile of istaroxime is being differentiated from currently available drugs used for this condition.”
Jed Latkin, Chief Executive Officer of Windtree, added, “The current treatment regime isn’t doing enough to help with this very severe condition, and we hope that as istaroxime advances to Phase 3, a new treatment paradigm will emerge. This interim look is yet another step on that path towards what we hope will be its eventual approval.”
Designed as a first-in-class dual-mechanism therapy, istaroxime aims to improve both systolic and diastolic cardiac function by enhancing myocardial contractility and relaxation. Earlier Phase 2 trials demonstrated its potential to improve cardiac function and blood pressure without raising heart rate or causing significant rhythm disturbances.
This latest progress underscores Windtree’s commitment to advancing innovative treatments for patients with limited options, positioning istaroxime as a promising candidate in transforming cardiogenic shock management.
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