Windtree Therapeutics to present istaroxime interim data at HFSA 2025.

Windtree Therapeutics announces interim data from the Phase 2 study of istaroxime in SEISMiC C, a cardiogenic shock SCAI Stage C study. The data is consistent with previous studies, leading the company to move forward with a global Phase 3 study. Istaroxime has a promising profile, with a 20-30% in-hospital mortality rate for SCAI Stage C cardiogenic shock. The HFSA Annual Scientific Meeting 2025 will feature a presentation on the safety and efficacy of istaroxime in patients with heart failure.

Title: Windtree Therapeutics Advances Istaroxime to Phase 3 for Cardiogenic Shock

Windtree Therapeutics (NASDAQ: WINT) has announced promising interim results from its Phase 2 SEISMiC C study evaluating istaroxime in patients with cardiogenic shock, specifically SCAI Stage C. The company has decided to proceed with a global Phase 3 trial based on the encouraging data [1].

The interim analysis, which included the first 20 patients, showed that istaroxime maintained its safety profile and demonstrated consistent physiological improvements when combined with current standard treatments. No new safety concerns or excess arrhythmias were identified, indicating that istaroxime can be safely administered alongside existing therapies [1].

The SEISMiC C study builds upon the successful SEISMIC B trial, where istaroxime improved critical parameters such as blood pressure, cardiac output, and organ perfusion in less severe shock patients. The consistent performance across different severity levels of heart failure suggests that istaroxime may have a broad therapeutic application across the spectrum of cardiogenic shock [1].

Windtree's 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 the safety and efficacy of istaroxime in patients with heart failure, highlighting the potential benefits for patients with low blood pressure due to heart failure [2].

Cardiogenic shock, particularly SCAI Stage C, has a high in-hospital mortality rate of 20-30%. The interim data from the SEISMiC C study provide sufficient confidence for Windtree to advance istaroxime to a global Phase 3 program, the final stage before potential regulatory submission. This milestone represents a significant step towards potential commercialization in a therapeutic area with substantial unmet medical need [1].

Istaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. It is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase and facilitates myocardial relaxation through activation of the SERCA2a calcium pump [1].

Windtree Therapeutics is a diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines. The company is actively seeking long-term development partners for its therapeutic pipelines [1].

References:
[1] https://www.stocktitan.net/news/WINT/windtree-announces-istaroxime-phase-2-interim-analysis-in-scai-stage-tq3utcfhxoi6.html
[2] https://www.stocktitan.net/news/WINT/windtree-announces-istaroxime-has-been-chosen-for-a-plenary-session-4byrc5wdj5mq.html