Windtree Therapeutics Announces Reduction In Arrythmias In A New Study With Istaroxime And A Pure SERCA2a Activator
Jan 02, 2024
The new preclinical data further supports istaroxime clinical data from three Phase 2 studies
Arrythmias can be a serious complication of current rescue therapies for treatment of patients with acute heart failure
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 (control). 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.
“This new data suggests that improving SERCA2a activity has the potential to improve arrythmia risk as well as improve overall cardiac function,” said
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.
Innovative drugs have the potential to treat acute heart failure and cardiogenic shock to improve cardiac function without increasing the risk for arrythmias. Acute decompensation of heart failure is responsible for approximately 1.3 million hospital admissions in the
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 Therapeutic’s research and development program is evaluating these preclinical product candidates, including oral and intravenous SERCA2a activator heart failure compounds.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are based on information available to the Company as of the date of this press release and are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include: risks and uncertainties associated with success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates; the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute on its operational and budget plans; the results, cost and timing of the Company’s clinical development programs, including any delays to such clinical trials relating to enrollment or site initiation; risks related to technology transfers to contract manufacturers and manufacturing development activities; delays encountered by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, and other materials on a timely basis and in sufficient amounts; risks relating to rigorous regulatory requirements, including that: (i) the
Source: Windtree Therapeutics