Windtree Completes Phase 2b Enrollment for Istaroxime in Early Cardiogenic Shock

Windtree Therapeutics, Inc. (NasdaqCM: WINT) has announced the successful completion of patient enrollment in its SEISMiC Extension Phase 2b study, which aims to evaluate istaroxime for early cardiogenic shock caused by heart failure. This study seeks to confirm and broaden the positive outcomes seen in Windtree's earlier SEISMIC Phase 2 clinical trial, particularly in improving heart function and alleviating low blood pressure in patients. Additionally, the company is focused on confirming the favorable renal profile and the lack of increased cardiac arrhythmias observed in earlier trials. The SEISMiC Extension Study employs longer dosing periods and tapered dosing to examine potential benefits.

Istaroxime is a first-in-class therapy known for enhancing both systolic contraction and diastolic relaxation of the heart. It also increases blood pressure and maintains or improves renal function in patients with compromised cardiac function, as demonstrated in three positive Phase 2 trials targeting acute heart failure (AHF). Cardiogenic shock, a severe condition that can occur when AHF patients deteriorate, results in the heart's inability to pump sufficient blood and oxygen to vital organs. The condition carries a significant mortality rate ranging from 7% to 40% in the U.S., depending on severity. Current pharmacological interventions are inadequate and often have side effects like arrhythmias, decreased blood pressure, and renal dysfunction, which restrict their use to severe cases. The global market for cardiogenic shock treatment is valued at approximately $1.25 billion annually.

The SEISMiC Extension Study, conducted across the U.S., Europe, and Latin America, builds on the previous positive results of the initial SEISMiC Phase 2 clinical study. It focuses on dose optimization and further characterizing istaroxime's novel SERCA2a mechanism in treating cardiogenic shock patients. The study includes hospitalized patients with early cardiogenic shock (SCAI Stage B) due to AHF and tests two different dosing regimens of istaroxime against a placebo. Participants received istaroxime infusions for up to 60 hours, with one group receiving a decreasing dose and the other a constant dose. This extended dosing duration, compared to the previous 24-hour treatment window, aims to explore additional benefits and determine the optimal dosing regimen for future late-stage trials. The study also collects detailed cardiac function data and safety information, particularly concerning cardiac arrhythmias. Notably, istaroxime has not been linked to an increase in cardiac arrhythmias, setting it apart from many current drug therapies.

Steve Simonson, MD, Chief Medical Officer and Senior Vice President of Windtree, highlighted the significance of completing enrollment in the SEISMiC Extension Study as a critical step toward advancing the istaroxime program to Phase 3. He also mentioned the ongoing SEISMiC C study targeting more severe cardiogenic shock patients. The company anticipates announcing topline results from the SEISMiC Extension Study by the end of the month and plans to present the data at a major medical conference soon.

Istaroxime is a dual-mechanism therapy designed to enhance both systolic and diastolic cardiac functions. As a positive inotropic agent, it increases myocardial contractility by inhibiting Na+/K+- ATPase and complements this by facilitating myocardial relaxation through the activation of the SERCA2a calcium pump, enhancing calcium reuptake from the cytoplasm. Multiple Phase 2 studies have shown that intravenous infusion of istaroxime significantly improves 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 preclinical precision aPKCi inhibitors for potential oncology applications. The company also engages in a licensing business model, with partnership out-licenses currently in place.

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