WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT), a Pennsylvania-based biotechnology company, has announced new preclinical data on two of its drug candidates, istaroxime and CVie-216. The drugs have shown promising reductions in ventricular arrhythmias in a rat heart model of diabetes with restricted and restored coronary blood flow induced injury.
Arrhythmias are irregular heartbeats that can significantly affect the pumping function of the heart, particularly in patients with heart failure and cardiomyopathy. They can impair the heart’s ability to fill with blood and its output to the body. Ventricular arrhythmias are especially dangerous and can be fatal.
Istaroxime and CVie-216 are designed to act on pumps in cardiac cells crucial for calcium handling. Istaroxime has a dual action mechanism, inhibiting the sodium-potassium ATPase and activating SERCA2a, while CVie-216 selectively activates SERCA2a.
Nearly 300 patients with acute decompensated heart failure were treated with istaroxime in three Phase 2 studies. These studies showed that istaroxime has not been associated with an increase in clinically significant arrhythmias, suggesting potential advantages over current rescue drug therapies used to treat acute heart failure and cardiogenic shock.
The latest study involved rats with diabetes whose hearts were exposed to restricted and restored coronary blood flow. The rats were infused with either istaroxime, CVie-216 or a placebo. The results demonstrated a reduction in arrhythmias in the groups treated with istaroxime and CVie-216 compared to the control group.
According to Windtree, these findings raise the possibility of new therapies that can improve cardiac function without increasing the risk of arrhythmias. Acute decompensation of heart failure is responsible for approximately 1.3 million hospital admissions in the U.S. and around 1.5 million in the EU each year. It is the leading cause of U.S. hospitalizations in patients over 65 years old and is the most expensive Medicare diagnosis to treat.
Furthermore, cardiogenic shock, a severe presentation of heart failure characterized by low blood pressure and inadequate blood flow to vital organs, has a mortality rate as high as 30-40% and substantial morbidity in survivors.
The company plans to publish the results and is in the process of pursuing additional intellectual property protection based on these findings.
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