Windtree Announces Istaroxime Presentation By Cardiogenic Shock Thought Leader At Cardiovascular Clinical Trials Conference
Windtree Therapeutics (WINT) announced that Dr. Alexandre Mebazaa, a leading expert in cardiogenic shock, presented data from the Phase 2b SEISMiC B study of istaroxime at the Cardiovascular Clinical Trials Conference in Washington, DC. Istaroxime, a first-in-class investigational therapy for early cardiogenic shock due to heart failure, has shown positive results in four Phase 2 trials. The drug demonstrated ability to rapidly increase blood pressure and improve cardiac output without increasing heart rate, while maintaining renal function and showing a favorable safety profile. The company plans to advance istaroxime to Phase 3 trials in cardiogenic shock treatment.
Windtree Therapeutics (WINT) ha annunciato che il Dr. Alexandre Mebazaa, esperto di spicco in shock cardiogeno, ha presentato dati dello studio di Fase 2b SEISMiC B su istaroxime durante la Conferenza sui Trial Cardiovascolari a Washington, DC. Istaroxime, una terapia innovativa in fase di investigazione per shock cardiogeno precoce causato da insufficienza cardiaca, ha mostrato risultati positivi in quattro studi di Fase 2. Il farmaco ha dimostrato la capacità di aumentare rapidamente la pressione sanguigna e migliorare la gittata cardiaca senza aumentare la frequenza cardiaca, mantenendo la funzione renale e mostrando un profilo di sicurezza favorevole. L'azienda prevede di avanzare istaroxime verso studi di Fase 3 nel trattamento dello shock cardiogeno.
Windtree Therapeutics (WINT) anunció que el Dr. Alexandre Mebazaa, un experto líder en shock cardiogénico, presentó datos del estudio de Fase 2b SEISMiC B sobre istaroxime en la Conferencia de Ensayos Clínicos Cardiovasculares en Washington, DC. Istaroxime, una terapia en investigación de primera línea para el shock cardiogénico temprano debido a la insuficiencia cardíaca, ha mostrado resultados positivos en cuatro ensayos de Fase 2. El medicamento demostró la capacidad de aumentar rápidamente la presión arterial y mejorar el gasto cardíaco sin aumentar la frecuencia cardíaca, mientras mantenía la función renal y mostraba un perfil de seguridad favorable. La empresa planea avanzar istaroxime a ensayos de Fase 3 en el tratamiento del shock cardiogénico.
Windtree Therapeutics (WINT)는 심장 충격의 전문가 알렉상드르 메바자 박사가 워싱턴 DC에서 열린 심혈관 임상 시험 회의에서 istaroxime에 대한 2b상 SEISMiC B 연구 데이터를 발표했다고 발표했습니다. Istaroxime은 심부전으로 인한 조기 심장 충격에 대한 최초의 혁신적 치료제이며, 4개의 2상 시험에서 긍정적인 결과를 보여주었습니다. 이 약물은 심박수를 증가시키지 않으면서 혈압을 빠르게 증가시키고 심박출량을 개선하는 능력을 보여주었으며, 신장 기능을 유지하고 안전성 프로필이 양호한 것으로 나타났습니다. 이 회사는 심장 충격 치료를 위한 3상 시험으로 istaroxime을 진행할 계획입니다.
Windtree Therapeutics (WINT) a annoncé que le Dr Alexandre Mebazaa, un expert reconnu en choc cardiogénique, a présenté des données de l'étude de Phase 2b SEISMiC B sur l'istaroxime lors de la Conférence sur les Essais Cliniques Cardiovasculaires à Washington, DC. L'istaroxime, une thérapie expérimentale de première classe pour le choc cardiogénique précoce dû à l'insuffisance cardiaque, a montré des résultats positifs dans quatre essais de Phase 2. Le médicament a démontré sa capacité à augmenter rapidement la pression artérielle et à améliorer le débit cardiaque sans augmenter la fréquence cardiaque, tout en maintenant la fonction rénale et en présentant un profil de sécurité favorable. L'entreprise prévoit de faire avancer l'istaroxime vers des essais de Phase 3 dans le traitement du choc cardiogénique.
Windtree Therapeutics (WINT) gab bekannt, dass Dr. Alexandre Mebazaa, ein führender Experte für kardiogenes Schock, Daten aus der Phase-2b-Studie SEISMiC B zu istaroxime auf der Konferenz für kardiovaskuläre klinische Studien in Washington, DC, präsentiert hat. Istaroxime, eine erstmalig getestete Forschungstherapie für frühen kardiogenen Schock bei Herzinsuffizienz, hat in vier Phase-2-Studien positive Ergebnisse gezeigt. Das Medikament zeigte die Fähigkeit, den Blutdruck schnell zu erhöhen und das Herzzeitvolumen zu verbessern, ohne die Herzfrequenz zu steigern, während die Nierenfunktion erhalten blieb und ein günstiges Sicherheitsprofil gezeigt wurde. Das Unternehmen plant, istaroxime in die Phase-3-Studien zur Behandlung kardiogenen Schocks voranzubringen.
- Positive results in four Phase 2 trials for istaroxime
- Drug demonstrates effective increase in blood pressure and cardiac output
- Favorable safety profile with no increase in significant arrhythmias
- Advancement to Phase 3 trials planned
- None.
Insights
WARRINGTON, Pa., Dec. 16, 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 Alexandre Mebazaa, MD, one of the world’s recognized leaders in cardiogenic shock, gave a well-received presentation highlighting the data on istaroxime from the recently completed Phase 2b SEISMiC B study in early cardiogenic shock due to heart failure. The presentation was given at the Cardiovascular Clinical Trials Conference in Washington, DC.
Dr. Alexandre Mebazaa is Professor of Medicine at Université Paris Cité (France), Chair of Department of Anesthesia & Critical Care and an expert in heart failure and cardiogenic shock. He is part of the task force that wrote the 2021 ESC/HFA Guidelines of Heart Failure and the 2023 addendum.
Early cardiogenic shock is characterized by low blood pressure, leaving the patient at risk of developing inadequate blood flow to vital organs leading to high morbidity and mortality. Istaroxime is a novel first-in-class investigational therapy that is intended to improve cardiac function and increase blood pressure to reverse the condition. Istaroxime maintains renal function and has a generally favorable safety profile. Istaroxime has been studied in four positive Phase 2 trials enrolling patients with acute heart failure and early cardiogenic shock due to heart failure.
“We are pleased that istaroxime is receiving positive attention based on the recent clinical trial results in treating patients with early cardiogenic shock. We believe that pharmacologic innovation is needed in treating patients with cardiogenic shock,” said Dr. Steve Simonson, CMO and SVP of Windtree. “Currently available drugs can have unwanted side effects and poor outcomes. There have been two positive istaroxime Phase 2 studies in early cardiogenic shock. Both have demonstrated the unique characteristics of rapidly and significantly increasing systolic blood pressure and improving cardiac output without increasing heart rate. Additionally, we have not seen an increase in clinically significant arrhythmias and istaroxime has maintained or improved renal function. We look forward to progressing istaroxime toward Phase 3 in cardiogenic shock.”
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 were the key results of WINT's Phase 2b SEISMiC B study for istaroxime?
How many Phase 2 trials has WINT completed for istaroxime in cardiogenic shock?
What is the next development phase for WINT's istaroxime?
What advantages does WINT's istaroxime show over current cardiogenic shock treatments?
