Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company specializing in advanced interventions for critical cardiovascular disorders, has announced novel preclinical data on its lead product candidate, istaroxime, and another pipeline drug candidate, CVie-216. The research showcased reductions in ventricular arrhythmias in a rat heart model of diabetes subjected to restricted and restored coronary blood flow-induced injury.

Istaroxime and CVie-216 target pumps in cardiac cells crucial for calcium handling. Istaroxime, a dual-action compound, inhibits sodium-potassium ATPase and activates SERCA2a. CVie-216 is designed to selectively activate SERCA2a.

In three Phase 2 studies, nearly 300 patients with acute decompensated heart failure, including those with early cardiogenic shock, received istaroxime treatment. The studies demonstrated that istaroxime wasn't associated with an increase in clinically significant arrhythmias, indicating its potential as a new therapy with advantages over current treatments for acute heart failure and cardiogenic shock.

To explore the benefits of SERCA2a activation on arrhythmia risk, Windtree conducted a study on rat hearts with diabetes, revealing a reduction in arrhythmias in istaroxime and CVie-216 pretreated groups compared to the control group. The company intends to publish these results and pursue additional intellectual property protection based on the findings.

Craig Fraser, CEO of Windtree Therapeutics, commented on the data, stating that improving SERCA2a activity has the potential to enhance arrhythmia risk and overall cardiac function. Ongoing clinical trials aim to gather more data on the impact of SERCA2a activation with istaroxime on clinically significant arrhythmias.

Arrhythmias pose a risk to patients with heart failure and cardiomyopathy, impacting the heart's pumping function. Ventricular arrhythmias, in particular, can be fatal. Windtree aims to develop innovative drugs that treat acute heart failure and cardiogenic shock, improving cardiac function without increasing arrhythmia risks.

Acute decompensation of heart failure leads to around 1.3 million hospital admissions in the U.S. and approximately 1.5 million in the EU. It is the leading cause of hospitalizations in the U.S. for patients over 65 and is the most expensive Medicare diagnosis to treat. Cardiogenic shock, a severe presentation of heart failure, has a mortality rate of 30-40%. Istaroxime is administered intravenously, while CVie-216 is in the preclinical stage and has the potential for intravenous or oral use in chronic heart failure.

Istaroxime, a first-in-class dual-mechanism therapy, enhances both systolic and diastolic cardiac function. It acts as a positive inotropic agent and increases myocardial contractility by inhibiting Na+/K+- ATPase. It also facilitates myocardial relaxation by activating the SERCA2a calcium pump on the sarcoplasmic reticulum.

Pure SERCA2a Activators, compounds that activate SERCA2a, are part of Windtree Therapeutic's research and development program. The company is evaluating these preclinical product candidates, including oral and intravenous SERCA2a activator heart failure compounds.

 

Source: globenewswire.com

Report Abuse