Windtree's Istaroxime Shows Promising Results in Phase 2 Study, Advances to Global Phase 3 Trial

Windtree Therapeutics announces that istaroxime has been selected for a plenary session presentation at the Heart Failure Society of America 2025. Interim data from the Phase 2 SEISMiC C study shows potential benefits for cardiogenic shock patients with consistent effects observed in previous studies. Windtree plans to advance istaroxime to a global Phase 3 study following promising results, addressing a significant unmet need in heart failure management.

Windtree Therapeutics (NASDAQ: WINT) has announced that its drug candidate, istaroxime, has been selected for a plenary session presentation at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025. The presentation will focus on interim data from the Phase 2 SEISMiC C study in cardiogenic shock patients [1].

The interim analysis of the first 20 patients showed promising results with no new safety concerns and no excess arrhythmias when combined with standard therapies. The drug's effects were consistent with previous studies, showing potential benefits for patients with low blood pressure due to heart failure. Notably, cardiogenic shock SCAI Stage C has a 20-30% in-hospital mortality rate [2].

Windtree's istaroxime shows promising interim Phase 2 results in cardiogenic shock, supporting advancement to Phase 3 for this high-mortality condition. The selection for a plenary session at HFSA 2025 indicates recognition of the data's significance within the cardiology community. The interim analysis revealed no new safety concerns or excess arrhythmias when istaroxime was combined with standard therapies, which is particularly noteworthy for heart failure treatments [1].

Istaroxime's mechanism offers a differentiated approach by improving cardiac function and increasing blood pressure without the heart rate elevation seen with many inotropes. Additionally, the preservation of renal function addresses a critical concern in heart failure management, as cardiorenal syndrome significantly complicates treatment and worsens outcomes [2].

The company's confidence to advance to a global Phase 3 program is scientifically justified based on these interim results. Given the lack of innovation in this therapeutic area for decades and the high unmet need in cardiogenic shock, successful development could represent a significant advancement for a patient population with limited treatment options [1].

Windtree Therapeutics, Inc. is a diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners. The company's announcement represents a meaningful clinical development milestone for istaroxime in cardiogenic shock SCAI Stage C, a critical condition with a 20-30% in-hospital mortality rate [2].

References:
[1] https://www.stocktitan.net/news/WINT/windtree-announces-istaroxime-has-been-chosen-for-a-plenary-session-4byrc5wdj5mq.html
[2] https://ir.windtreetx.com/news-releases/news-release-details/windtree-announces-istaroxime-has-been-chosen-plenary-session