Windtree Announces Istaroxime Phase 2 Cardiogenic Shock Study Hits Enrollment Target for Planned Interim Analysis
Windtree Therapeutics (NASDAQ:WINT) has achieved its target enrollment of 20 patients for the interim analysis of its Phase 2 SEISMiC C study, evaluating istaroxime in SCAI Stage C cardiogenic shock patients. The study represents the third trial in the company's istaroxime cardiogenic shock development program, following two previously successful Phase 2 studies in SCAI Stage B patients.
The SEISMiC C trial is a global, placebo-controlled, double-blinded study conducted across the U.S., Europe, and Latin America. The study evaluates istaroxime in combination with standard care treatments, including inotropes and vasopressors. The primary endpoint focuses on systolic blood pressure profile during the first six hours of treatment.
The interim analysis will primarily assess preliminary safety, tolerability, and efficacy signals to determine appropriate sizing for the remainder of the trial. The company notes that a statistically significant efficacy signal is not expected at this interim stage. The data from this study will be crucial for Phase 3 readiness and upcoming FDA discussions.
Windtree Therapeutics (NASDAQ:WINT) ha raggiunto l'obiettivo di arruolamento di 20 pazienti per l'analisi intermedia del suo studio di Fase 2 SEISMiC C, che valuta l'istaroxime in pazienti con shock cardiogeno in stadio SCAI C. Lo studio rappresenta il terzo trial nel programma di sviluppo dell'istaroxime per lo shock cardiogeno dell'azienda, dopo due precedenti studi di Fase 2 di successo su pazienti in stadio SCAI B.
Il trial SEISMiC C è uno studio globale, controllato con placebo e in doppio cieco, condotto negli Stati Uniti, in Europa e in America Latina. Lo studio valuta l'istaroxime in combinazione con i trattamenti standard, inclusi inotropi e vasopressori. L'endpoint primario si concentra sul profilo della pressione arteriosa sistolica durante le prime sei ore di trattamento.
L'analisi intermedia valuterà principalmente segnali preliminari di sicurezza, tollerabilità ed efficacia per determinare la dimensione appropriata per il resto dello studio. L'azienda sottolinea che non è prevista una significatività statistica dell'efficacia in questa fase intermedia. I dati di questo studio saranno fondamentali per la preparazione della Fase 3 e per le prossime discussioni con la FDA.
Windtree Therapeutics (NASDAQ:WINT) ha alcanzado su objetivo de reclutamiento de 20 pacientes para el análisis intermedio de su estudio de Fase 2 SEISMiC C, que evalúa istaroxima en pacientes con shock cardiogénico en etapa SCAI C. Este estudio representa el tercer ensayo en el programa de desarrollo de istaroxima para shock cardiogénico de la compañía, tras dos estudios previos de Fase 2 exitosos en pacientes en etapa SCAI B.
El ensayo SEISMiC C es un estudio global, controlado con placebo y doble ciego, realizado en EE. UU., Europa y América Latina. El estudio evalúa istaroxima en combinación con tratamientos estándar, incluidos inotrópicos y vasopresores. El objetivo principal se centra en el perfil de presión arterial sistólica durante las primeras seis horas de tratamiento.
El análisis intermedio evaluará principalmente señales preliminares de seguridad, tolerabilidad y eficacia para determinar el tamaño adecuado para el resto del ensayo. La compañía señala que no se espera una señal de eficacia estadísticamente significativa en esta etapa intermedia. Los datos de este estudio serán cruciales para la preparación de la Fase 3 y las próximas discusiones con la FDA.
Windtree Therapeutics (NASDAQ:WINT)는 SCAI 단계 C 심인성 쇼크 환자를 대상으로 하는 2상 SEISMiC C 연구의 중간 분석을 위해 20명의 환자 등록 목표를 달성했습니다. 이 연구는 회사의 istaroxime 심인성 쇼크 개발 프로그램에서 세 번째 임상시험으로, 이전에 SCAI 단계 B 환자를 대상으로 성공적으로 완료된 두 건의 2상 연구에 이은 것입니다.
SEISMiC C 시험은 미국, 유럽, 라틴 아메리카에서 진행되는 글로벌, 위약 대조, 이중맹검 연구입니다. 이 연구는 인오트로프 및 바소프레서 등 표준 치료와 istaroxime의 병용 효과를 평가합니다. 주요 평가 변수는 치료 첫 6시간 동안의 수축기 혈압 프로파일입니다.
중간 분석은 주로 예비 안전성, 내약성 및 효능 신호를 평가하여 나머지 시험의 적절한 규모를 결정하는 데 중점을 둡니다. 회사는 이 중간 단계에서 통계적으로 유의한 효능 신호는 기대하지 않는다고 밝혔습니다. 이 연구의 데이터는 3상 준비와 FDA와의 향후 논의에 매우 중요할 것입니다.
Windtree Therapeutics (NASDAQ:WINT) a atteint son objectif d'inclusion de 20 patients pour l'analyse intermédiaire de son étude de Phase 2 SEISMiC C, évaluant l'istaroxime chez des patients en choc cardiogénique au stade SCAI C. Cette étude représente le troisième essai dans le programme de développement de l'istaroxime pour le choc cardiogénique de la société, après deux études de Phase 2 réussies chez des patients au stade SCAI B.
L'essai SEISMiC C est une étude mondiale, contrôlée par placebo et en double aveugle, menée aux États-Unis, en Europe et en Amérique latine. L'étude évalue l'istaroxime en association avec les traitements standards, y compris les inotropes et vasopresseurs. Le critère principal porte sur le profil de la pression artérielle systolique durant les six premières heures de traitement.
L'analyse intermédiaire évaluera principalement les signaux préliminaires de sécurité, tolérance et efficacité afin de déterminer la taille appropriée pour le reste de l'essai. La société précise qu'un signal d'efficacité statistiquement significatif n'est pas attendu à ce stade intermédiaire. Les données de cette étude seront cruciales pour la préparation de la Phase 3 et les prochaines discussions avec la FDA.
Windtree Therapeutics (NASDAQ:WINT) hat das Ziel erreicht, 20 Patienten für die Zwischenanalyse der Phase-2-Studie SEISMiC C einzuschreiben, die Istaroxim bei Patienten mit kardiogenem Schock im SCAI-Stadium C untersucht. Die Studie ist die dritte Prüfung im kardiogenen Schock-Entwicklungsprogramm des Unternehmens für Istaroxim, nach zwei zuvor erfolgreichen Phase-2-Studien bei Patienten im SCAI-Stadium B.
Die SEISMiC C-Studie ist eine weltweite, placebokontrollierte, doppelblinde Studie, die in den USA, Europa und Lateinamerika durchgeführt wird. Untersucht wird Istaroxim in Kombination mit Standardbehandlungen, einschließlich Inotropika und Vasopressoren. Der primäre Endpunkt konzentriert sich auf das systolische Blutdruckprofil während der ersten sechs Behandlungsstunden.
Die Zwischenanalyse wird hauptsächlich vorläufige Sicherheits-, Verträglichkeits- und Wirksamkeitssignale bewerten, um die geeignete Größe für den Rest der Studie zu bestimmen. Das Unternehmen weist darauf hin, dass in dieser Zwischenphase kein statistisch signifikanter Wirksamkeitseffekt erwartet wird. Die Daten dieser Studie sind entscheidend für die Vorbereitung der Phase 3 und die bevorstehenden Gespräche mit der FDA.
- None.
- Statistically significant efficacy signal not anticipated at interim analysis
- Targeting more severe SCAI Stage C patients with historically high mortality rates
- Complex treatment environment with patients already receiving multiple medications
Insights
Windtree's istaroxime advances with interim analysis enrollment in severe cardiogenic shock; results will inform Phase 3 design and FDA discussions.
Windtree has achieved a significant clinical development milestone by reaching the target enrollment of 20 patients needed for the interim analysis of its Phase 2 SEISMiC C study. This represents the third clinical study in their istaroxime cardiogenic shock program, now focusing on more severely ill SCAI Stage C patients after reporting positive results in two earlier studies with less severe Stage B patients.
The trial design is robust - it's placebo-controlled, double-blinded, and evaluates istaroxime added to standard of care (including inotropes and vasopressors). The primary endpoint is systolic blood pressure profile over six hours, with secondary measures including cardiac function, specific timepoint blood pressure changes, and the vasopressor-inotrope score.
This interim analysis is primarily focused on safety and tolerability in this sicker patient population rather than efficacy signals. The company isn't expecting statistically significant efficacy at this interim stage, which is appropriate for this development phase. What's particularly valuable is that including SCAI Stage C patients now will inform the design of their Phase 3 program and upcoming FDA end-of-Phase 2 meeting.
Cardiogenic shock represents a serious unmet medical need with high mortality rates despite current treatments. If istaroxime continues to show promise, it could potentially offer a differentiated mechanism compared to existing therapies. The company's progression toward Phase 3 readiness is methodical and follows standard drug development pathways for critical care medications.
The SEISMiC C Study is the third study in the istaroxime cardiogenic shock development program - SEISMiC C is studying more severely ill SCAI Stage C cardiogenic shock patients
Windtree has previously reported two positive early cardiogenic shock Phase 2 studies in SCAI Stage B patients
The SEISMiC C interim analysis will provide a preliminary assessment of istaroxime safety in treating more severe cardiogenic shock patients who may be receiving standard of care with inotropes and vasopressors
SCAI Stage C is a sicker patient population than early cardiogenic shock and has high mortality despite currently used drug treatments
WARRINGTON, Pa., June 30, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a diversified company focused on revenue generation in multiple growing industries is pleased to announce that the Company has reached the planned enrollment of 20 patients for the interim analysis in its istaroxime Phase 2 SEISMiC C study in SCAI Stage C cardiogenic shock patients.
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, including inotropes or vasopressors. The primary endpoint of the study is the systolic blood pressure (“SBP”) profile over the first six hours of treatment when istaroxime is used with this background therapy in more severe patients. Other key study measurements include various measures of cardiac function, SBP changes at specified timepoints, the vasopressor-inotrope score, avoidance of progression to more severe shock in addition to other clinical assessments. The interim analysis will be primarily looking at preliminary safety and tolerability in this setting and an assessment of preliminary efficacy signals to appropriately size the remainder of the SEISMiC C trial. A statistically significant efficacy signal is not anticipated at the interim analysis.
The Company believes that this SCAI stage C study will be valuable for Phase 3 readiness of istaroxime in cardiogenic shock because these patients will be an important population for the target indication in the Phase 3 study. The Company also expects these data to be useful in its planned end of Phase 2 meeting with FDA.
“We are pleased to reach the study enrollment needed for the interim analysis in SCAI Stage C patients with cardiogenic shock,” said Steve Simonson, M.D., Chief Medical Officer of Windtree. “As we make progress toward Phase 3 readiness for istaroxime, we believe the profile of istaroxime is being differentiated from currently available drugs used for this condition.”
“The Company continues to make progress towards its ultimate goal of assisting in bringing this drug candidate to market,” said Jed Latkin, Chief Executive Officer of Windtree. “The current treatment regime isn’t doing enough to help with this very severe condition, and we hope that as istaroxime advances to Phase 3, a new treatment paradigm will emerge. This interim look is yet another step on that path towards what we hope will be its eventual approval.”
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 can significantly improve cardiac function and blood pressure without increasing heart rate or the incidence of clinically significant cardiac rhythm disturbances.
About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is a diversified company focused on becoming a revenue generating company in a multitude of growing industries to drive toward overall profitability.
Forward Looking Statements
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 risks and uncertainties associated with the success and advancement of its product candidates; the Company’s ability to manage costs and execute on its operational and budget plans; 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 regulatory requirements; 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 impacts of political unrest, including as a result of geopolitical tension, 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. 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
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