Windtree Therapeutics is advancing istaroxime, a first-in-class therapy, for early cardiogenic shock, with recent data presented at the Cardiovascular Clinical Trials Conference in Washington, DC. The presentation highlighted findings from the Phase 2b SEISMiC B study, showcasing istaroxime's potential to improve cardiac function and increase blood pressure in patients with early cardiogenic shock due to heart failure.
Istaroxime's Clinical Profile
Istaroxime is designed to enhance both systolic and diastolic cardiac function through a dual mechanism. It acts as a positive inotropic agent by inhibiting Na+/K+-ATPase, increasing myocardial contractility. Additionally, it facilitates myocardial relaxation by activating the SERCA2a calcium pump, enhancing calcium reuptake. Clinical data from Phase 2 trials indicate that intravenous istaroxime significantly improves cardiac function and blood pressure without elevating heart rate or causing cardiac rhythm disturbances.
"We are pleased that istaroxime is receiving positive attention based on the recent clinical trial results in treating patients with early cardiogenic shock. We believe that pharmacologic innovation is needed in treating patients with cardiogenic shock," said Dr. Steve Simonson, CMO and SVP of Windtree.
Addressing Unmet Needs in Cardiogenic Shock
Early cardiogenic shock is characterized by low blood pressure, posing a high risk of inadequate blood flow to vital organs, leading to significant morbidity and mortality. Current treatments often have undesirable side effects and limited effectiveness. Istaroxime aims to address these limitations by improving cardiac output and maintaining renal function, as demonstrated in multiple Phase 2 studies.
Patent Filing for Arrhythmia Prevention
Windtree has also filed a national phase patent application in India for istaroxime, focusing on preventing or reducing the risk of acute myocardial arrhythmia. This application is based on data from animal model testing and human clinical trials, including the Phase 2b study in early cardiogenic shock patients. The company's studies have indicated that istaroxime does not increase clinically significant cardiac arrhythmias while improving heart function and blood pressure.
"India’s population is greater than 1.4 billion people making it a part of our istaroxime strategic intellectual property plan," said Jed Latkin, CEO of Windtree. "As we prepare for Phase 3 readiness in cardiogenic shock, we plan to obtain intellectual property protection in key markets such as India."
Future Directions
Windtree is progressing istaroxime toward Phase 3 clinical trials in cardiogenic shock. The company believes that istaroxime's unique characteristics, including its ability to improve cardiac function and blood pressure without increasing heart rate or arrhythmias, could differentiate it from existing treatments.
