Windtree Begins SEISMiC C Study of Istaroxime in Stage C Cardiogenic Shock for Phase 2b Completion and Phase 3 Transition

Windtree Therapeutics, Inc., a biotechnology firm committed to developing advanced therapies for critical conditions, has announced the commencement of patient enrollment in the SEISMiC C trial. This study focuses on SCAI Stage C cardiogenic shock, a severe form of heart failure. The SEISMiC C trial is a progression from the successful SEISMiC A and B studies, which showed promising results in SCAI Stage B cardiogenic shock.

The SEISMiC C trial aims to treat patients with more advanced cardiogenic shock, where heart failure has led to insufficient blood flow and oxygen to vital organs. These patients often require inotropic or vasopressor drugs, which can have harmful side effects. Istaroxime, the drug being tested, has shown potential to avoid these side effects based on previous studies.

This trial is an international, placebo-controlled, double-blinded study conducted in the U.S., Europe, and Latin America. Istaroxime will be administered along with current standard treatments, and its effects will be closely monitored over six hours. The primary goal is to assess improvements in systolic blood pressure (SBP) during this period. Other important measurements include various aspects of cardiac function, changes in SBP at specific times, and the necessity for mechanical cardiac support, among others.

The study will include a planned review after about 20 patients with SCAI Stage C cardiogenic shock have been enrolled. This review, scheduled for late Q1 or early Q2 of 2025, will help guide the number of additional patients needed and the timing for completing the study.

The aim of SEISMiC C is to provide comprehensive data on istaroxime's effectiveness and its potential advantages over existing treatments. This data is crucial for discussions with regulatory authorities as Windtree prepares for Phase 3 of the clinical trial. The inclusion of SCAI Stage C patients in Phase 3 is significant because it represents the target population for the intended treatment.

Steve Simonson, CMO and SVP of Windtree Therapeutics, expressed optimism about the trial, stating that it builds on positive results from earlier studies and moves the company closer to Phase 3 development. The successful outcome of SEISMiC C is expected to facilitate a smooth transition to Phase 3, focusing on treating SCAI Stage C cardiogenic shock patients.

Istaroxime is a first-in-class dual-mechanism therapy designed to enhance both systolic and diastolic cardiac function. It increases myocardial contractility by inhibiting Na+/K+-ATPase and facilitates myocardial relaxation through the activation of the SERCA2a calcium pump. Data from multiple Phase 2 studies have shown that istaroxime significantly improves cardiac function and blood pressure without raising heart rate or causing cardiac rhythm disturbances.

Windtree Therapeutics, Inc. is dedicated to advancing innovative therapies for critical medical conditions. Their product portfolio includes istaroxime, a Phase II candidate 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 out-licenses currently in place.

As Windtree progresses with the SEISMiC C study, the company remains focused on achieving a successful Phase 3 transition and ultimately providing a new treatment option for patients with severe cardiogenic shock.