Windtree Therapeutics Announces Presentation of Preclinical Data on Istaroxime and a Selective SERCA2a Activator at the European Society of Cardiology Heart Failure Conference May 17, 2025

Rhea-AI Summary

Windtree Therapeutics (NASDAQ: WINT) announced the presentation of preclinical data on istaroxime and a selective SERCA2a activator at the upcoming European Society of Cardiology Heart Failure Conference. The ePoster presentation demonstrates how istaroxime and its metabolite analog (CVie216) help reduce calcium-dependent arrhythmias in an STZ rat model during ischemia-reperfusion by activating SERCA2a.

The study identified a potential mechanism explaining the decreased incidence of reperfusion-induced arrhythmias in STZ-isolated hearts after exposure to these compounds. This research is particularly significant as arrhythmias can severely impact heart function and can be fatal, especially in patients with heart failure and cardiomyopathy.

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Biotechnology Research Scientist

Windtree presents encouraging preclinical data showing istaroxime may reduce dangerous cardiac arrhythmias through SERCA2a activation in heart failure.

Windtree Therapeutics is advancing its research on istaroxime and a selective SERCA2a activator (CVie216) with new preclinical data to be presented at the European Society of Cardiology Heart Failure Conference. The findings provide a mechanistic explanation for previously observed benefits in reducing arrhythmias during ischemia-reperfusion conditions.

The research evaluated the compounds' effects on spontaneous calcium release (SCR) events from the sarcoplasmic reticulum in a STZ rat model. This calcium handling pathway is critical in cardiac function, as dysregulated calcium cycling often contributes to arrhythmias in heart failure patients. By activating SERCA2a, istaroxime appears to help normalize calcium cycling, potentially reducing the risk of dangerous arrhythmias.

This work represents an important step in understanding how istaroxime provides its anti-arrhythmic benefits. Arrhythmias pose significant risks for heart failure patients, as they can severely compromise cardiac output and, in ventricular forms, prove fatal. Current heart failure treatments, particularly catecholamines, can sometimes exacerbate arrhythmia risk, creating a therapeutic challenge.

While still preclinical, this research strengthens the mechanistic foundation of istaroxime's potential clinical benefits by elucidating its effects on calcium-dependent pathways central to cardiac electrical stability. The compound's dual action - inhibiting Na+/K+-ATPase while activating SERCA2a - gives it a unique profile among heart failure therapeutics that may eventually provide advantages in reducing arrhythmic complications.

ePoster presentation advances the preclinical evaluation of the importance of SERCA2a function to reduce arrythmias with istaroxime and a selective SERCA2a activator in the setting of ischemia and reperfusion

WARRINGTON, Pa., May 12, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies for critical conditions and diseases, today announced istaroxime and a selective SERCA2a activator data furthering the demonstration of reduction in arrythmias in an animal study. The data is in a poster presentation at the European Society of Cardiology Heart Failure Conference.

Windtree Therapeutics will present an e-poster at the ESC Heart Failure Congress on the impact of istaroxime and its metabolite analog (CVie216) in activating sarcoplasmic reticulum (SR) Ca2+-ATPase, commonly known as SERCA2a, to reduce Ca2+-dependent arrhythmias in the STZ rat model induced by ischemia-reperfusion. This extends previous work that demonstrated a favorable impact of istaroxime and CVie216 on ischemia-reperfusion arrhythmias. The current experiments assessed the incidence of spontaneous calcium release (SCR) events from the sarcoplasmic reticulum. The findings identify a potential mechanism to explain the decreased incidence of reperfusion-induced arrhythmias in STZ-isolated hearts observed after exposure to istaroxime and CVie216.

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.

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 Selective 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.

About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is a biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase 2 candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place.

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, among other things: the Company’s ability to secure significant additional capital as and when needed; the Company’s ability to achieve the intended benefits of the aPKCi asset acquisition with Varian Biopharmaceuticals, Inc.; the Company’s risks and uncertainties associated with the success and advancement of the clinical development programs for istaroxime and the Company’s other product candidates, including preclinical oncology candidates; 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 U.S. Food and Drug Administration or other regulatory authorities may not agree with the Company on matters raised during regulatory reviews, may require significant additional activities, or may not accept or may withhold or delay consideration of applications, or may not approve or may limit approval of the Company’s product candidates, and (ii) changes in the national or international political and regulatory environment may make it more difficult to gain regulatory approvals and risks related to the Company’s efforts to maintain and protect the patents and licenses related to its product candidates; risks that the Company may never realize the value of its intangible assets and have to incur future impairment charges; risks related to the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to service those markets; the Company’s ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of the Company’s product candidates, if approved; the economic and social consequences of the COVID-19 pandemic and the impacts of political unrest, including as a result of geopolitical tension, including the conflict between Russia and Ukraine, the People’s Republic of China and the Republic of China (Taiwan), and the evolving events in Israel and Gaza, and any sanctions, export controls or other restrictive actions that may be imposed by the United States and/or other countries which could have an adverse impact on the Company’s operations, including through disruption in supply chain or access to potential international clinical trial sites, and through disruption, instability and volatility in the global markets, which could have an adverse impact on the Company’s ability to access the capital markets. These and other risks are described in the Company’s periodic reports, including its Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, filed with or furnished to the Securities and Exchange Commission and available at www.sec.gov. Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

Contact Information:
Eric Curtis
ecurtis@windtreetx.com

FAQ

What will Windtree Therapeutics (WINT) present at the ESC Heart Failure Conference 2025?

Windtree will present an ePoster showing how istaroxime and its metabolite analog (CVie216) reduce calcium-dependent arrhythmias in an STZ rat model by activating SERCA2a during ischemia-reperfusion.

What is the significance of WINT's arrhythmia research findings?

The research identified a mechanism that explains how istaroxime and CVie216 decrease reperfusion-induced arrhythmias in STZ-isolated hearts, which is important as arrhythmias can be fatal in heart failure patients.

How do arrhythmias affect heart failure patients?

Arrhythmias in heart failure patients can impair proper blood filling of the heart, reduce cardiac output to the body, and can be potentially fatal, especially ventricular arrhythmias.

What causes arrhythmias in heart failure patients?

Arrhythmias in heart failure patients can be caused by their underlying cardiac disease or by drugs used to treat heart failure, such as catecholamines.