Windtree Announces Istaroxime has been Chosen for a Plenary Session Presentation at the Heart Failure Society of America 2025
Windtree Therapeutics (NASDAQ:WINT) announced that its drug candidate istaroxime has been selected for a plenary session presentation at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025. The presentation will focus on interim data from the Phase 2 SEISMiC C study in cardiogenic shock patients.
The interim analysis of the first 20 patients showed promising results with no new safety concerns and no excess arrhythmias when combined with standard therapies. The drug's effects were consistent with previous studies, showing potential benefits for patients with low blood pressure due to heart failure. Notably, cardiogenic shock SCAI Stage C has a 20-30% in-hospital mortality rate.
Windtree Therapeutics (NASDAQ:WINT) ha comunicato che il suo candidato farmacologico istaroxime 猫 stato selezionato per una presentazione in sessione plenaria al Congresso Annuale 2025 della Heart Failure Society of America (HFSA). L'intervento illustrer脿 i dati interim dello studio di Fase 2 SEISMiC C su pazienti in shock cardiogeno.
L'analisi interinale dei primi 20 pazienti ha evidenziato risultati promettenti, senza nuovi problemi di sicurezza n茅 aumento delle aritmie quando il farmaco 猫 stato associato alle terapie standard. Gli effetti osservati sono coerenti con studi precedenti e indicano potenziali benefici per pazienti con pressione arteriosa bassa dovuta a insufficienza cardiaca. Va ricordato che lo shock cardiogeno SCAI Stadio C presenta un tasso di mortalit脿 ospedaliera del 20-30%.
Windtree Therapeutics (NASDAQ:WINT) anunci贸 que su candidato farmacol贸gico istaroxime ha sido seleccionado para una presentaci贸n en sesi贸n plenaria en la Reuni贸n Cient铆fica Anual 2025 de la Heart Failure Society of America (HFSA). La ponencia se centrar谩 en los datos provisionales del estudio de Fase 2 SEISMiC C en pacientes con shock cardiog茅nico.
El an谩lisis interino de los primeros 20 pacientes mostr贸 resultados prometedores, sin nuevas se帽ales de seguridad ni aumento de arritmias cuando se administr贸 junto con las terapias est谩ndar. Los efectos del f谩rmaco coinciden con estudios previos, sugiriendo beneficios potenciales para pacientes con tensi贸n arterial baja por insuficiencia card铆aca. Cabe destacar que el shock cardiog茅nico SCAI Estadio C tiene una tasa de mortalidad hospitalaria del 20-30%.
Windtree Therapeutics (NASDAQ:WINT)電� 鞛愳偓鞚� 鞎诫 頉勲炒 istaroxime鞚� Heart Failure Society of America(HFSA) 2025 鞐半 頃欖垹雽�須岇棎靹� 鞝勳泊須岇潣 氚滍憸搿� 靹犾爼霅橃棃雼り碃 氚滍憸頄堨姷雼堧嫟. 氚滍憸鞐愳劀電� 鞁澑靹� 靽柬伂 頇橃瀽毳� 雽�靸侅溂搿� 頃� 2靸� SEISMiC C 鞐瓣惮鞚� 欷戧皠 雿办澊韯瓣皜 靻岅皽霅� 鞓堨爼鞛呺媹雼�.
觳� 20氇呾潣 頇橃瀽鞐� 雽�頃� 欷戧皠攵勳劃鞐愳劀 靸堧鞖� 鞎堨爠靹� 鞖半牑雮� 響滌 旃橂鞕� 氤戩毄 鞁� 攵�鞝曤Д 歃濌皜 鞐嗢澊 鞙犽頃� 瓴瓣臣臧� 雮橅儉雮姷雼堧嫟. 鞎诫鞚� 須臣電� 鞚挫爠 鞐瓣惮霌り臣 鞚检箻頃橂┌, 鞁秬鞝勳溂搿� 鞚疙暅 鞝�順堨晻 頇橃瀽鞐愱矊 鞛犾灛鞝� 鞚措摑鞚� 鞁滌偓頃╇媹雼�. 彀戈碃搿� 鞁澑靹� 靽柬伂 SCAI C雼硠鞚� 鞛呾洂 欷� 靷毳犾潃 20-30%鞛呺媹雼�.
Windtree Therapeutics (NASDAQ:WINT) a annonc茅 que son candidat-m茅dicament istaroxime a 茅t茅 retenu pour une pr茅sentation en s茅ance pl茅ni猫re lors de la R茅union Scientifique Annuelle 2025 de la Heart Failure Society of America (HFSA). La pr茅sentation portera sur les donn茅es interm茅diaires de l'茅tude de phase 2 SEISMiC C chez des patients en choc cardiog茅nique.
L'analyse interm茅diaire des 20 premiers patients a montr茅 des r茅sultats encourageants, sans nouveaux signaux de s茅curit茅 et sans survenue accrue d'arythmies en association avec les traitements standards. Les effets du m茅dicament sont coh茅rents avec les 茅tudes ant茅rieures et sugg猫rent des b茅n茅fices potentiels pour les patients pr茅sentant une hypotension li茅e 脿 une insuffisance cardiaque. Il est notable que le choc cardiog茅nique SCAI stade C pr茅sente un taux de mortalit茅 hospitali猫re de 20鈥�30%.
Windtree Therapeutics (NASDAQ:WINT) teilte mit, dass sein Wirkstoffkandidat istaroxime f眉r eine Plenarvorstellung auf dem Annual Scientific Meeting 2025 der Heart Failure Society of America (HFSA) ausgew盲hlt wurde. Die Pr盲sentation wird sich auf Zwischenbefunde der Phase-2-Studie SEISMiC C bei Patienten mit kardiogenem Schock konzentrieren.
Die Zwischenanalyse der ersten 20 Patienten ergab vielversprechende Resultate ohne neue Sicherheitsbedenken und ohne vermehrte Arrhythmien bei Kombination mit Standardtherapien. Die Wirkungen stimmen mit fr眉heren Studien 眉berein und deuten auf m枚gliche Vorteile f眉r Patienten mit herzinsuffizienzbedingtem niedrigem Blutdruck hin. Bemerkenswert ist, dass der kardiogene Schock SCAI Stufe C eine station盲re Sterblichkeitsrate von 20鈥�30% aufweist.
- Interim Phase 2 data showed no new safety concerns
- Drug effects were consistent with previous positive study results
- Company plans to advance to global Phase 3 study
- Drug shows potential to improve cardiac function without increasing heart rate
- None.
Insights
Windtree's istaroxime shows promising interim Phase 2 results in cardiogenic shock, supporting advancement to Phase 3 for this high-mortality condition.
Windtree Therapeutics' announcement represents a meaningful clinical development milestone for istaroxime in cardiogenic shock SCAI Stage C, a critical condition with
The interim analysis of the first 20 patients in the SEISMiC C study revealed no new safety concerns or excess arrhythmias when istaroxime was combined with standard therapies. This safety profile is particularly noteworthy for heart failure treatments, where arrhythmogenic side effects often limit therapeutic options. The consistent hemodynamic and echocardiographic improvements align with previous study results, suggesting reproducible efficacy.
Istaroxime's mechanism offers a differentiated approach by improving cardiac function and increasing blood pressure without the heart rate elevation seen with many inotropes. Additionally, the preservation of renal function addresses a critical concern in heart failure management, as cardiorenal syndrome significantly complicates treatment and worsens outcomes.
The company's confidence to advance to a global Phase 3 program is scientifically justified based on these interim results. Given the lack of innovation in this therapeutic area for decades and the high unmet need in cardiogenic shock, successful development could represent a significant advancement for a patient population with limited treatment options.
Presentation will be the interim data from the Phase 2 study of istaroxime in SEISMiC C - Cardiogenic Shock SCAI Stage C
Cardiogenic shock SCAI Stage C has an in hospital mortality rate of 20
Istaroxime interim data was consistent with the profile seen in previous studies gives Windtree confidence to move forward with a global Phase 3 study
WARRINGTON, Pa., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (鈥淲indtree鈥� or the 鈥淐ompany鈥�) (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, announced that istaroxime was chosen for a presentation entitled, 鈥淪afety and Efficacy of intravenous administration of istaroxime for 48 hours in patients with SCAI Stage C cardiogenic shock due to heart failure鈥� at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2025.
Acute decompensated heart failure and cardiogenic shock have had very little drug innovation in decades. The Company believes istaroxime has a profile that offers potential benefits to patients with low blood pressure due to heart failure. Istaroxime improves cardiac function and can increase blood pressure without increasing heart rate. Also, istaroxime tends to preserve measures of renal function and contributes to resolution of congestion and fluid overload that often accompanies heart failure. Importantly, it does not appear to increase clinically significant arrythmias. The istaroxime cardiogenic shock SCAI Stage C interim analysis included the first 20 patients enrolled in the study. There were no new safety concerns identified, and no apparent excess arrythmias 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.
鈥淲e are very pleased with the interim results of the SEISMiC C study,鈥� said Jed Latkin, Chief Executive Officer of Windtree. 鈥淲e believe istaroxime can be an important drug innovation for acute decompensated heart failure and cardiogenic shock patients because the istaroxime studies have promising results and this is a condition with a large unmet need and has been underserved for decades.鈥�
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 鈥減redicts,鈥� 鈥渂elieves,鈥� 鈥減otential,鈥� 鈥減roposed,鈥� 鈥渃ontinue,鈥� 鈥渆stimates,鈥� 鈥渁nticipates,鈥� 鈥渆xpects,鈥� 鈥減lans,鈥� 鈥渋ntends,鈥� 鈥渕ay,鈥� 鈥渃ould,鈥� 鈥渕ight,鈥� 鈥渨ill,鈥� 鈥渟hould,鈥� 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鈥檚 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鈥檚 ability to manage costs and execute on its operational and budget plans. These and other risks are described in the Company鈥檚 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
FAQ
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