Windtree Therapeutics Initiates SEISMiC C Study of Istaroxime in SCAI Stage C Cardiogenic Shock for Planned Completion of Phase 2b and Transition to Phase 3
Windtree Therapeutics (WINT) has initiated enrollment in the SEISMiC C trial for SCAI Stage C cardiogenic shock, following positive results from SEISMiC A and B trials. The study evaluates istaroxime in more severely ill patients who require inotropic or vasopressor drugs. The global, placebo-controlled trial will assess istaroxime's effectiveness when added to standard care, with primary focus on systolic blood pressure profile over 6 hours. A data review is planned for late Q1/early Q2 2025. Previous trials showed istaroxime improved blood pressure, cardiac and renal function without increased arrhythmia risks.
Windtree Therapeutics (WINT) ha avviato l'arruolamento nel trial SEISMiC C per shock cardiogeno di stadio C SCAI, dopo i risultati positivi ottenuti negli studi SEISMiC A e B. Lo studio valuta l'istaroxime in pazienti gravemente malati che necessitano di farmaci inotropi o vasopressori. Il trial globale, controllato con placebo, valuterà l'efficacia dell'istaroxime quando aggiunto alla terapia standard, concentrandosi principalmente sul profilo della pressione arteriosa sistolica nel corso di 6 ore. È prevista una revisione dei dati per la fine del Q1/inizio del Q2 2025. I trial precedenti hanno mostrato che l'istaroxime ha migliorato la pressione arteriosa, la funzione cardiaca e renale senza aumentare i rischi di aritmia.
Windtree Therapeutics (WINT) ha iniciado el reclutamiento en el ensayo SEISMiC C para el shock cardiogénico en etapa C SCAI, tras los resultados positivos de los ensayos SEISMiC A y B. El estudio evalúa el istaroxime en pacientes más gravemente enfermos que requieren fármacos inotrópicos o vasopresores. El ensayo global, controlado con placebo, evaluará la efectividad del istaroxime cuando se añade a la atención estándar, con un enfoque principal en el perfil de presión arterial sistólica durante 6 horas. Se prevé una revisión de datos para finales del Q1/principios del Q2 de 2025. Los ensayos anteriores mostraron que el istaroxime mejoró la presión arterial, la función cardíaca y renal sin aumentar los riesgos de arritmia.
Windtree Therapeutics (WINT)는 SEISMiC A 및 B 시험에서 긍정적인 결과를 바탕으로 SCAI C단계 심인성 쇼크를 위한 SEISMiC C 시험 참여자를 모집하기 시작했습니다. 이 연구는 인토로픽 또는 혈관 수축제 약물이 필요한 중증 환자에서 이스타록심을 평가합니다. 이 글로벌 위약 대조 시험은 이스타록심이 표준 치료에 추가되었을 때의 효과를 평가하며, 6시간 동안의 수축기 혈압 프로파일에 주로 초점을 맞춥니다. 데이터 검토는 2025년 1분기 말 또는 2분기 초에 계획되어 있습니다. 이전의 시험들은 이스타록심이 혈압과 심장 및 신장 기능을 개선했지만 부정맥 위험을 증가시키지 않았음을 보여주었습니다.
Windtree Therapeutics (WINT) a lancé le recrutement dans l'essai SEISMiC C pour le choc cardiogène de stade C SCAI, suite aux résultats positifs des essais SEISMiC A et B. L'étude évalue l'istaroxime chez des patients plus gravement malades nécessitant des médicaments inotropes ou vasopresseurs. L'essai mondial, contrôlé par placebo, évaluera l'efficacité de l'istaroxime lorsqu'il est ajouté aux soins standard, avec un accent principal sur le profil de pression artérielle systolique sur 6 heures. Un examen des données est prévu pour la fin du T1/début du T2 2025. Les essais précédents ont montré que l'istaroxime améliorait la pression artérielle, ainsi que la fonction cardiaque et rénale, sans augmenter les risques d'arythmie.
Windtree Therapeutics (WINT) hat mit der Rekrutierung für die SEISMiC-C-Studie bei SCAI-Stadium-C-Kardiogenem Schock begonnen, nachdem positive Ergebnisse aus den SEISMiC-A- und B-Studien vorliegen. Die Studie bewertet Istaroxim bei schwerer erkrankten Patienten, die inotrope oder vasopressorische Medikamente benötigen. Die globale, placebo-kontrollierte Studie wird die Wirksamkeit von Istaroxim in Verbindung mit der Standardversorgung untersuchen, mit dem Hauptaugenmerk auf dem systolischen Blutdruckprofil über einen Zeitraum von 6 Stunden. Eine Datenüberprüfung ist für Ende Q1/Anfang Q2 2025 geplant. Frühere Studien zeigten, dass Istaroxim den Blutdruck sowie die Herz- und Nierenfunktion verbesserte, ohne das Risiko von Arrhythmien zu erhöhen.
- Previous SEISMiC A and B trials showed positive results
- Istaroxime demonstrated improved systolic blood pressure, cardiac and renal function
- No increased risk for cardiac arrhythmias compared to current medications
- None.
Insights
The initiation of the SEISMiC C trial represents a significant milestone in istaroxime's development pathway. Previous positive results from SEISMiC A and B trials showed improvements in systolic blood pressure, cardiac function and renal function without increased arrhythmia risks - a key differentiator from current treatments.
The expansion into SCAI Stage C cardiogenic shock is particularly noteworthy as it targets a more severe patient population. This global, placebo-controlled study could potentially demonstrate istaroxime's ability to reduce dependence on current standard-of-care treatments that have concerning side effects. The comprehensive endpoint measurements, including the vasopressor-inotrope score and prevention of progression to more severe stages, will provide important efficacy data.
The planned interim data review in Q1/Q2 2025 will be pivotal for Phase 3 preparation. For a micro-cap company with
After successful SEISMiC A and B studies in Early Cardiogenic Shock, SEISMiC C will treat more severe SCAI Stage C cardiogenic shock to complete the assessment of the intended Phase 3 patient population
Windtree plans to engage with regulatory authorities in 2025 for Transition to Phase 3 clinical trial
WARRINGTON, Pa., Oct. 30, 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 the initiation of enrollment in the SEISMiC C trial in SCAI Stage C cardiogenic shock. This study follows the positive results in both SEISMiC A and B in SCAI Stage B cardiogenic shock trials. In these trials, istaroxime improved systolic blood pressure, cardiac function and renal function without an increased risk for cardiac arrhythmias, a profile that differentiates istaroxime from currently used medications to treat shock. SCAI Stage C cardiogenic shock is a more severely ill population than was previously studied with istaroxime. SCAI Stage C patients have progressed in their cardiogenic shock and heart failure to the point of tissue and vital organ hypoperfusion (lack of blood flow and oxygen) and typically require inotropic or vasopressor drugs for support. These drugs are used with caution due to deleterious side effects – many of which we believe istaroxime may potentially avoid based on results to date from four previous studies in acute heart failure and early cardiogenic shock. The Company intends to include SCAI Stage C patients as part of the Phase 3 patient population for cardiogenic shock.
The SEISMiC C study is a global trial including sites in the U.S,. Europe and Latin America. It is a placebo-controlled, double-blinded study with istaroxime being added to current standard of care, inotropes or vasopressors. The effect of istaroxime in addition to these therapies will be assessed for 6 hours and based on the patient’s condition, a withdrawal of the other therapies. The primary endpoint of the study is assessment of systolic blood pressure (SBP) profile over the first 6 hours of treatment. Other key study measurements include various measures of cardiac function, SBP changes at specified timepoints, the vasopressor-inotrope score, avoidance of progression to SCAI Stage D or E cardiogenic shock and need for mechanical cardiac support, time to treatment failure, arrhythmia assessments, days alive and out of the hospital through day 30, physiologic measures (e.g., cardiac index) and length of stay in the intensive care unit and hospital. There will be a planned data review after enrollment of approximately 20 subjects with SCAI Stage C cardiogenic shock due to acute decompensated heart failure planned for late Q1 / early Q2 2025 followed by guidance from the Company on the number of additional patients and timing to complete the study and planned Phase 2 completion.
The Company believes that the data from SEISMiC C trial will help characterize the potential advantages of istaroxime compared to current standard of care therapies and that this SCAI Stage C trial is important for Phase 3 readiness of istaroxime in cardiogenic shock because these patients are intended to be part of the target patient population. The Company expects these data to also be useful for discussions with regulatory agencies to finalize plans for the Phase 3 program design.
“We are pleased to have this study underway and enrolling patients. The study is intended to build on the positive results to date and moves us forward into this important SCAI Stage C patient population for the development program,” said Steve Simonson, CMO and SVP of Windtree Therapeutics. “With SCAI Stage C acceptable results, we expect to move steadily 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 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 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 II 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 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:
Eric Curtis
ecurtis@windtreetx.com
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