Windtree Announces New Istaroxime Patent Filing for Preventing or Reducing the Risk of Acute Myocardial Arrhythmia
Windtree Therapeutics has filed a new PCT patent application for istaroxime derivatives aimed at preventing or reducing the risk of acute myocardial arrhythmia. The filing builds on data from animal model testing and human clinical trials for acute heart failure (AHF) and early cardiogenic shock (ECS), including a positive Phase 2b study in ECS patients. Istaroxime has demonstrated beneficial effects in rat studies with ischemia-reperfusion induced arrhythmias, showing potential as a therapeutic for improving cardiac function in patients with ischemia. The drug has shown no increase in clinically significant cardiac arrhythmias in Phase 2 trials, potentially due to its SERCA2a activation, differentiating it from current treatments. The company believes these unique aspects justify intellectual property protection.
Windtree Therapeutics ha presentato una nuova domanda di brevetto PCT per i derivati dell'istaroxime volti a prevenire o ridurre il rischio di aritmia miocardica acuta. La domanda si basa su dati provenienti da test su modelli animali e studi clinici umani per l'insufficienza cardiaca acuta (AHF) e lo shock cardiogeno precoce (ECS), inclusi uno studio positivo di Fase 2b su pazienti con ECS. L'istaroxime ha dimostrato effetti benefici in studi su ratti con aritmie indotte da ischemia-riperfusione, mostrando un potenziale terapeutico per migliorare la funzione cardiaca nei pazienti con ischemia. Il farmaco non ha mostrato alcun aumento di aritmie cardiache clinicamente significative negli studi di Fase 2, potenzialmente a causa della sua attivazione di SERCA2a, che lo distingue dai trattamenti attuali. La società crede che questi aspetti unici giustifichino la protezione della proprietà intellettuale.
Windtree Therapeutics ha presentado una nueva solicitud de patente PCT para los derivados de istaroxime destinados a prevenir o reducir el riesgo de arritmia miocárdica aguda. La solicitud se basa en datos de pruebas en modelos animales y ensayos clínicos humanos para la insuficiencia cardíaca aguda (AHF) y el shock cardiogénico temprano (ECS), incluyendo un estudio positivo de Fase 2b en pacientes con ECS. El istaroxime ha demostrado efectos beneficiosos en estudios con ratas con arritmias inducidas por isquemia-reperfusión, mostrando potencial como terapia para mejorar la función cardíaca en pacientes con isquemia. El fármaco no ha mostrado un aumento en arritmias cardíacas clínicamente significativas en ensayos de Fase 2, potencialmente debido a su activación de SERCA2a, lo que lo diferencia de los tratamientos actuales. La empresa cree que estos aspectos únicos justifican la protección de la propiedad intelectual.
윈트리 테라퓨틱스는 급성 심실 빈맥의 위험을 예방하거나 줄이기 위해 이스타록심 유도체에 대한 새로운 PCT 특허 신청을 제출했습니다. 이 신청은 급성 심부전 (AHF) 및 초기 심인성 쇼크 (ECS) 환자에 대한 동물 모델 테스트 및 임상 시험에서 수집된 데이터를 바탕으로 하며, ECS 환자에 대한 긍정적인 2b상 연구를 포함합니다. 이스타록심은 허혈-재관류 유도 아리트미아를 가진 쥐 연구에서 유익한 효과를 보여주었으며, 허혈 환자의 심장 기능 개선을 위한 치료제로서의 잠재력을 나타냈습니다. 이 약물은 2상 시험에서 임상적으로 중요한 심장 부정맥의 증가를 보이지 않았으며, 이는 현재 치료법과의 차별점이 되는 SERCA2a 활성화 때문일 수 있습니다. 회사는 이러한 독특한 측면이 지적재산권 보호를 정당화한다고 믿고 있습니다.
Windtree Therapeutics a déposé une nouvelle demande de brevet PCT pour des dérivés de l'istaroxime visant à prévenir ou réduire le risque d'arythmie myocardique aiguë. La demande s'appuie sur des données provenant d'essais sur des modèles animaux et des essais cliniques humains pour l'insuffisance cardiaque aiguë (AHF) et le choc cardiogénique précoce (ECS), y compris une étude positive de Phase 2b chez des patients ECS. L'istaroxime a démontré des effets bénéfiques dans des études sur des rats avec des arythmies induites par ischémie-réperfusion, montrant un potentiel en tant que thérapie pour améliorer la fonction cardiaque chez les patients souffrant d'ischémie. Le médicament n'a montré aucun augmentation d'arythmies cardiaques cliniquement significatives lors des essais de Phase 2, potentiellement en raison de son activation de SERCA2a, ce qui le différencie des traitements actuels. L'entreprise estime que ces aspects uniques justifient la protection de propriété intellectuelle.
Windtree Therapeutics hat einen neuen PCT-Patentantrag für Istaroxim-Derivate eingereicht, die darauf abzielen, das Risiko akuter myokardialer Arrhythmien zu verhindern oder zu reduzieren. Der Antrag basiert auf Daten aus Tests an Tiermodellen und humanen klinischen Studien zur akuten Herzinsuffizienz (AHF) und frühzeitigen kardiogenen Schock (ECS), einschließlich einer positiven Phase-2b-Studie bei ECS-Patienten. Istaroxim hat in Studien an Ratten mit durch Ischämie-Reperfusion induzierten Arrhythmien positive Effekte gezeigt und besitzt somit potenzielles therapeutisches Potenzial zur Verbesserung der Herzfunktion bei Ischämie-Patienten. In Phase-2-Studien zeigte das Medikament keinen Anstieg klinisch signifikanter Herzarrhythmien, möglicherweise aufgrund seiner SERCA2a-Aktivierung, die es von den aktuellen Therapien unterscheidet. Das Unternehmen ist der Meinung, dass diese einzigartigen Aspekte einen Schutz des geistigen Eigentums rechtfertigen.
- New PCT patent application for istaroxime derivatives aimed at preventing or reducing acute myocardial arrhythmia.
- Positive Phase 2b clinical trial results in ECS patients.
- Istaroxime showed beneficial effects in animal models with ischemia-reperfusion induced arrhythmias.
- No increase in clinically significant cardiac arrhythmias observed in Phase 2 trials.
- None.
Insights
The patent filing for istaroxime's potential anti-arrhythmic properties represents an incremental development in Windtree's intellectual property portfolio, but with immediate impact. While the data from animal studies and Phase 2 trials suggests promising safety characteristics regarding arrhythmia risk, this patent filing is primarily a defensive IP strategy rather than a significant value-driving event.
The key differentiator lies in istaroxime's SERCA2a activation mechanism, which appears to improve cardiac function without increasing arrhythmia risk - a common concern with traditional inotropes. However, this is still early-stage data and the path to commercialization remains long and capital-intensive. For a micro-cap company with resources, the ability to fully capitalize on this potential advantage remains uncertain.
The clinical implications of istaroxime's potential anti-arrhythmic properties are intriguing from a therapeutic perspective. Current treatments for cardiogenic shock and acute heart failure often come with significant arrhythmia risks, creating a challenging risk-benefit balance. The absence of increased arrhythmia incidence in Phase 2 trials, combined with positive efficacy signals, suggests a potentially favorable safety profile.
However, it's important to note that this is based on Phase 2 data and preclinical models. The true clinical significance and commercial potential will require validation in larger Phase 3 trials. The patent filing, while potentially valuable for future market protection, doesn't materially change the near-term clinical development timeline or risk profile.
WARRINGTON, Pa., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced that it has filed a new istaroxime PCT patent application entitled, “ISTAROXIME DERIVATIVES THEREOF FOR PREVENTING OR REDUCING THE RISK OF ACUTE MYOCARDIAL ARRHYTHMIA.”
The patent filing expands upon data obtained from animal model testing and the istaroxime human clinical trials in acute heart failure (AHF) and early cardiogenic shock (ECS), including the latest positive Phase 2b istaroxime study in ECS patients. Istaroxime has also shown beneficial effects in rat studies with ischemia-reperfusion induced arrhythmias. Istaroxime-metabolite derivatives have shown superior properties in these models indicating their potential as promising therapeutics for the treatment of patients with ischemia needing improvement in cardiac function.
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.
“In our Phase 2 clinical program, we have not seen an increase in clinically significant cardiac arrhythmias in istaroxime treated patients while improving heart function and blood pressure in treated patients,” said Dr. Steve Simonson, CMO and SVP of Windtree. “We believe this characteristic may be related to SERCA2a activation by istaroxime and it has the potential to differentiate istaroxime from current drug treatments for cardiogenic shock and AHF including inotropes and vasopressors. With the results of our clinical program thus far and the additional animal model data, we determined there are unique aspects that warrant filing for intellectual property protection.”
About Istaroxime
Istaroxime is a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is designed as 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 have demonstrated that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances.
About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is a biotechnology company focused on 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 statements related to the potential clinical effects of istaroxime; the potential benefits and safety of istaroxime; the clinical development of istaroxime; and our research and development program for treating patients in early cardiogenic shock due to heart failure. Such statements constitute 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 secure and successfully complete an out-licensing or asset acquisition transaction; 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 the Middle East, 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:
Windtree:
Eric Curtis
ecurtis@windtreetx.com
New Growth Advisors:
Stephen Cervieri
scervieri@ngadvisorsltd.com
FAQ
What is the new patent filing by Windtree Therapeutics about?
What were the results of the Phase 2b study for istaroxime?
How does istaroxime impact cardiac arrhythmias according to recent studies?
Why did Windtree Therapeutics file for a new patent on istaroxime?
