Windtree Reports Positive Phase 2b SEISMiC Extension Results for Istaroxime in Early Cardiogenic Shock

Windtree Therapeutics, Inc., a biotechnology company, has announced positive outcomes from its Phase 2b SEISMiC Extension Study of istaroxime. This study demonstrated a significant improvement in systolic blood pressure over a six-hour period, a key clinical target for patients experiencing early cardiogenic shock due to heart failure. These results will be presented at the Heart Failure Society of America Medical Conference on September 30, 2024.

The SEISMiC Extension Study, conducted in the United States, Europe, and Latin America, focused on the impacts of istaroxime on blood pressure and cardiac function over a 96-hour monitoring period, ending with a final check-up at 30 days. This study builds on the positive findings from the earlier Phase 2 SEISMiC trial. Its primary goal was to enhance low blood pressure and cardiac function in early cardiogenic shock patients and to gather data to better understand the optimal dosing and the mechanisms of action for istaroxime, including the potential benefits of SERCA2a activation.

Involving patients with SCAI Stage B cardiogenic shock, the study assessed two different dosing regimens of istaroxime against a placebo. Patients received infusions for up to 60 hours; one group had a decreasing dosage over time, while the other had a constant dosage. By extending the duration beyond the previous 24-hour treatment limit, the study aimed to explore if a longer duration could offer more benefits, which is crucial for determining the best dosing regimen for future trials. Detailed data on cardiac and renal functions, as well as additional safety information regarding cardiac arrhythmias, were collected. Notably, istaroxime has not been linked to an increase in cardiac arrhythmias, a significant advantage over current therapies.

The study's primary endpoint was met with a significant improvement in systolic blood pressure over six hours, where the combined istaroxime group outperformed the placebo group. Significant benefits were also observed in numerous secondary endpoints. The safety profile was favorable and aligned with previous clinical trials.

Further details will be unveiled at the Heart Failure Society of America Meeting, followed by a press release and an investor call to discuss more comprehensive results.

Dr. Steve Simonson, Senior Vice President and Chief Medical Officer at Windtree, expressed satisfaction with the study results, highlighting the potential of istaroxime to benefit patients with acute heart failure and early cardiogenic shock. He emphasized the extensive data collected on blood pressure profiles, cardiac function, and safety measures for the two dosing regimens, looking forward to sharing more insights at the upcoming medical meeting.

Craig Fraser, Chairman and CEO of Windtree, pointed out the high need for new drug innovations for cardiogenic shock, a condition with high morbidity and mortality. He noted that across four Phase 2 studies, istaroxime had shown a unique and compelling profile as a potential therapy for cardiogenic shock and acute heart failure. Fraser expressed excitement about sharing more detailed study results and progressing towards Phase 3 readiness for istaroxime.

Istaroxime is described as a first-in-class dual-mechanism therapy aimed at improving both systolic and diastolic cardiac functions. It acts as a positive inotropic agent and enhances myocardial relaxation through SERCA2a activation. Various Phase 2 studies have shown that intravenous istaroxime significantly improved cardiac function and blood pressure without increasing heart rate or causing cardiac rhythm disturbances.

Windtree Therapeutics, Inc. is committed to advancing innovative therapies for critical conditions and diseases, with a portfolio that includes istaroxime for acute heart failure and cardiogenic shock, preclinical SERCA2a activators for heart failure, and precision aPKCi inhibitors for oncology applications. The company also engages in licensing partnerships to further its development efforts.