Windtree Announces Istaroxime Phase 2 Interim Analysis in SCAI Stage C Cardiogenic Shock Patients
Windtree Therapeutics (NASDAQ:WINT) has announced positive interim analysis results from its SEISMiC C Phase 2 study evaluating istaroxime in SCAI Stage C cardiogenic shock patients. The study demonstrated that istaroxime maintained its safety profile and showed consistent physiological improvements when combined with current standard treatments.
The global, placebo-controlled, double-blinded trial included sites across the U.S., Europe, and Latin America, building upon previous successful SEISMIC B study results. The interim analysis of the first 20 patients revealed no new safety concerns or excess arrhythmias when istaroxime was administered alongside standard therapies. The company plans to advance to a global Phase 3 trial based on these encouraging results.
Windtree Therapeutics (NASDAQ:WINT) ha annunciato risultati positivi dall'analisi intermedia del suo studio SEISMiC C di Fase 2 che valuta l'istaroxime in pazienti con shock cardiogeno SCAI Stadio C. Lo studio ha dimostrato che l'istaroxime mantiene il suo profilo di sicurezza e mostra miglioramenti fisiologici costanti quando combinato con i trattamenti standard attuali.
Lo studio globale, controllato con placebo e in doppio cieco, ha coinvolto centri negli Stati Uniti, in Europa e in America Latina, basandosi sui risultati positivi del precedente studio SEISMIC B. L'analisi intermedia dei primi 20 pazienti non ha evidenziato nuove preoccupazioni di sicurezza né un aumento delle aritmie quando l'istaroxime è stato somministrato insieme alle terapie standard. L'azienda prevede di procedere con un trial globale di Fase 3 basandosi su questi risultati promettenti.
Windtree Therapeutics (NASDAQ:WINT) ha anunciado resultados positivos del análisis interino de su estudio SEISMiC C de Fase 2 que evalúa istaroxima en pacientes con shock cardiogénico en estadio SCAI C. El estudio demostró que istaroxima mantuvo su perfil de seguridad y mostró mejoras fisiológicas consistentes cuando se combinó con los tratamientos estándar actuales.
El ensayo global, controlado con placebo y doble ciego, incluyó sitios en EE. UU., Europa y América Latina, basándose en los exitosos resultados previos del estudio SEISMIC B. El análisis interino de los primeros 20 pacientes no reveló nuevas preocupaciones de seguridad ni un exceso de arritmias cuando se administró istaroxima junto con las terapias estándar. La compañía planea avanzar a un ensayo global de Fase 3 basándose en estos alentadores resultados.
Windtree Therapeutics (NASDAQ:WINT)는 SCAI 단계 C 심인성 쇼크 환자를 대상으로 istaroxime을 평가한 SEISMiC C 2상 연구의 중간 분석 결과 긍정적임을 발표했습니다. 연구 결과 istaroxime이 안전성 프로파일을 유지하며 현재 표준 치료와 병용 시 일관된 생리학적 개선을 보였습니다.
미국, 유럽, 라틴 아메리카 전역의 사이트를 포함한 글로벌 무작위 위약 대조 이중 맹검 시험으로, 이전 SEISMIC B 연구의 성공적인 결과를 기반으로 합니다. 첫 20명 환자에 대한 중간 분석에서 istaroxime을 표준 치료와 함께 투여했을 때 새로운 안전성 문제나 과도한 부정맥이 발견되지 않았습니다. 회사는 이 고무적인 결과를 바탕으로 글로벌 3상 시험으로 진행할 계획입니다.
Windtree Therapeutics (NASDAQ:WINT) a annoncé des résultats positifs d'une analyse intermédiaire de son étude de phase 2 SEISMiC C évaluant l'istaroxime chez des patients en choc cardiogénique au stade SCAI C. L'étude a montré que l'istaroxime conservait son profil de sécurité et apportait des améliorations physiologiques constantes lorsqu'il était associé aux traitements standards actuels.
Cette étude mondiale, contrôlée par placebo et en double aveugle, a inclus des sites aux États-Unis, en Europe et en Amérique latine, s'appuyant sur les résultats positifs de l'étude SEISMIC B précédente. L'analyse intermédiaire des 20 premiers patients n'a révélé aucune nouvelle préoccupation de sécurité ni d'arythmies excessives lors de l'administration d'istaroxime en complément des thérapies standards. La société prévoit de passer à un essai mondial de phase 3 sur la base de ces résultats encourageants.
Windtree Therapeutics (NASDAQ:WINT) hat positive Zwischenergebnisse aus der Phase-2-Studie SEISMiC C zur Bewertung von Istaroxim bei SCAI-Stadium C kardiogenem Schock bekanntgegeben. Die Studie zeigte, dass Istaroxim sein Sicherheitsprofil beibehält und in Kombination mit den aktuellen Standardbehandlungen konsistente physiologische Verbesserungen aufweist.
Die globale, placebokontrollierte, doppelblinde Studie umfasste Standorte in den USA, Europa und Lateinamerika und baut auf den erfolgreichen Ergebnissen der vorherigen SEISMIC B-Studie auf. Die Zwischenanalyse der ersten 20 Patienten ergab keine neuen Sicherheitsbedenken oder vermehrte Arrhythmien bei gleichzeitiger Gabe von Istaroxim und Standardtherapien. Das Unternehmen plant, basierend auf diesen vielversprechenden Ergebnissen eine globale Phase-3-Studie durchzuführen.
- No new safety concerns identified in interim analysis
- Consistent positive hemodynamic and echocardiographic results with previous studies
- Successful combination with existing standard of care treatments
- Study results support advancement to Phase 3 trials
- Limited interim data from only 20 patients
- Still requires successful completion of full Phase 2 trial
- Company actively seeking development partners for pipeline
Insights
Positive interim Phase 2 results for istaroxime in severe cardiogenic shock support advancement to Phase 3, potentially addressing a critical treatment gap.
Windtree's interim analysis of istaroxime in SCAI Stage C cardiogenic shock shows promising results in a patient population with greater disease severity than previously studied. The drug maintained its established safety profile even when combined with current standard treatments (inotropes and vasopressors), with no new safety signals identified. This is particularly significant as cardiogenic shock represents a severe heart failure presentation with high mortality rates and limited effective treatment options.
The SEISMiC C study builds upon previous positive results from the SEISMIC B trial, where istaroxime improved critical parameters including blood pressure, cardiac output, and organ perfusion in less severe shock patients. What makes these results especially meaningful is that istaroxime demonstrated consistent physiological improvements even in combination therapy scenarios with existing medications - a difficult hurdle for many cardiovascular drugs.
The consistent performance across different severity levels of heart failure suggests istaroxime may have a broad therapeutic application across the spectrum of cardiogenic shock. These interim data provide sufficient confidence for Windtree to advance to a global Phase 3 program, the final stage before potential regulatory submission. For a small biopharmaceutical company, reaching Phase 3 with positive data represents a significant milestone toward potential commercialization in a therapeutic area with substantial unmet medical need.
Istaroxime was added to currently available inotropes and vasopressors in the study - no new safety signals were identified and physiological improvements were consistent with istaroxime responses in previous trials
Cardiogenic shock is a severe presentation of heart failure and SCAI Stage C patients have low blood pressure and signs of organ damage due to low blood flow
These data provide the Company confidence to move forward with a global Phase 3 trial
WARRINGTON, Pa., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a diversified company with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners, has performed a planned interim analysis of the SEISMiC C Phase 2 study data evaluating istaroxime in SCAI Stage C cardiogenic shock which showed istaroxime had a similar profile to that seen in previous studies despite a greater severity of illness and being used in addition to currently available inotropes and vasopressors.
The SEISMiC C Study is a global trial including sites in the U.S., Europe and Latin America. It is placebo-controlled, double-blinded study with istaroxime being added to current standard of care, including inotropes or vasopressors in patients with more severe cardiogenic shock (SCAI stage C) than has been studied previously. The study follows the results of the SEISMIC B study where istaroxime was shown to improve blood pressure and hemodynamic variables such as cardiac output (the amount of blood pumped by the heart per minute), reduced filling pressures in the heart and improved signs of organ perfusion such as mixed venous oxygenation in patients with milder cardiogenic shock (SCAI stage B). This data is contributing to a very unique profile of istaroxime in acute decompensated heart failure across severity of illness. Inotropes and vasopressors agents are given to many patients in intensive care units in the USA every year and the results of the SEISMIC program may suggest potential advantages to istaroxime over existing therapies in efficacy and possibly safety. The SESIMIC C study was designed to assess the effects of istaroxime in patients with SCAI Stage C cardiogenic shock (i.e., more severe cardiogenic shock than patients enrolled in previous acute heart failure and cardiogenic shock studies in the past). Many patients in SESIMIC C were treated at the time of enrollment with vasopressors or inotropes and hence the SESIMIC C study is testing for the first time the safety and efficacy of istaroxime in more severe cardiogenic shock when istaroxime treatment is combined with other therapies for cardiogenic shock.
The interim analysis included the first 20 patients enrolled in the study. There were no new safety concerns identified, and no apparent excess arrhythmias in patients treated with istaroxime when given with standard of care therapies. The effects on hemodynamic and echocardiographic measures appeared to be consistent with results seen in previous istaroxime studies.
“The results of the SEISMIC C interim analysis are exciting,” said Jed Latkin, Chief Executive Officer of Windtree. “We believe these data will be instrumental in moving istaroxime to a global Phase 3 program in heart failure and cardiogenic shock. Steve Simonson, Chief Medical Officer added, “The interim data are consistent with the previous clinical study results seen in patients with AHF and less severe forms of cardiogenic shock. These data are encouraging for the potential of istaroxime to be effective across the spectrum of cardiogenic shock due to AHF with or without other inotropic or vasopressor drugs.”
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 with several divisions, including a cryptocurrency treasury strategy and two promising therapeutic pipelines for which the Company is actively seeking long-term development partners.
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 success of the SEISMiC C Study, the ability to move istaroxime to a global Phase 3 program and risks related to the Company’s ability to manage costs and execute on its operational and budget plans. 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 were the key findings of Windtree's (WINT) istaroxime Phase 2 interim analysis?
How many patients were included in WINT's SEISMiC C Phase 2 interim analysis?
What is the difference between SEISMIC B and SEISMIC C trials for WINT's istaroxime?
What are Windtree's (WINT) next steps for istaroxime development?
How does istaroxime differ from current cardiogenic shock treatments?
