Windtree Therapeutics announces reduction in arrythmias in istaroxime study

Windtree Therapeutics announced new preclinical data on the company’s lead product candidate, istaroxime, and another preclinical pipeline drug candidate, CVie-216, showing reductions in ventricular arrythmias in a rat heart model of diabetes with restricted and restored coronary blood flow induced injury. Istaroxime and CVie-216 are each designed to act on pumps in the cardiac cells that are important in calcium handling. Istaroxime is a dual mechanism of action compound that has been shown to inhibit the sodium potassium ATPase and activates SERCA2a. CVie-216 is designed to selectively activate SERCA2a. Nearly 300 patients with acute decompensated heart failure were treated with istaroxime in three Phase 2 studies, including a study that evaluated patients with early cardiogenic shock. In these studies, istaroxime has not been associated with an increase in clinically significant arrythmias, raising the potential for a new therapy with substantial advantages over current rescue drug therapies used to treat acute heart failure and cardiogenic shock. Windtree is continuing to obtain data to evaluate the potential benefits of SERCA2a activation on arrythmia risk in all ongoing clinical trials. To further explore this potential benefit associated with SERCA2a activation, Windtree conducted a study of restricted and restored coronary blood flow induced injury in the hearts of rats with diabetes that were infused with either istaroxime, pure SERCA2a activator CVie-216 or placebo. The rat model generated a reproducible incidence of ventricular arrythmias. This study demonstrated a reduction in arrythmias in the istaroxime and CVie-216 pretreated groups compared to the control group. The company plans to publish the results and is in the process of pursuing additional intellectual property protection based on these findings.