Windtree Therapeutics, Inc. announced that it has renewed its partnership with Chang Gung University in Taiwan to further research on SERCA2a, an important target for the Company?s cardiovascular portfolio. Windtree personnel from its offices in Taipei, Taiwan will participate in the collaboration. The scientific collaboration includes the Company?s lead product candidate istaroxime and the next generation compounds called SERCA2a activators.

One of istaroxime?s mechanisms of action is facilitation of myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. SERCA2a activity is decreased in heart failure and disordered calcium handling can play a role in cardiac arrythmias. Windtree believes activation of SERCA2a could represent an important advancement in heart failure treatment for patients.

The SERCA2a activators are in the preclinical stage of development and have potential for intravenous administration or oral (tablet) use in the out-patient setting in chronic heart failure. Arrythmias are irregular heartbeats that can impact the pumping function of the heart. Patients with heart failure and cardiomyopathy are at risk for arrythmias.

Arrythmias in these patients can be caused by their underlying cardiac disease or by drugs used to treat the heart failure such as catecholamines. Arrythmias can impair proper filling of the heart with blood and, importantly, cardiac output to the body. Ventricular arrythmias are particularly dangerous and can be fatal.

Outside of this scientific collaboration, istaroxime is being studied in the Phase 2 SEISMiC Extension Study in early cardiogenic shock. Study results are expected in mid-2024. Cardiogenic shock is a serious condition that occurs when the heart is failing significantly and cannot pump enough blood and oxygen to the brain, kidneys, and other vital organs.

Mortality rates are significant and, depending on severity, range from 7% to 40% in the U.S. There is a lack of satisfactory pharmacological intervention to reverse the condition as available therapies have unwanted side effects such as risk for arrhythmias, decreasing blood pressure, renal dysfunction and even increases in mortality that limit their usefulness and position them as ?rescue medicines? for severe cases. Market research revealed 99% of 100 U.S.-based clinical cardiologists interviewed who treat cardiogenic shock patients responded that new drug innovation to treat these patients is highly needed.

The cardiogenic shock worldwide total market value is estimated to be $1.25 billion, calculated by using cardiogenic shock patient U.S. hospital claims and worldwide prevalence data multiplied by assumed various regional prices of drug treatment. About Istaroxime: Istaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm.

Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances. About Pure SERCA2a Activators: These compounds activate SERCA2a and Windtree Therapeutics' research and development program is evaluating these preclinical product candidates, including oral and intravenous SERCA2a activator heart failure compounds.