Windtree Announces Positive Topline Results from Its Phase 2b SEISMiC Extension Study of Istaroxime in Early Cardiogenic Shock
Windtree Therapeutics (NasdaqCM: WINT) announced positive topline results from its Phase 2b SEISMiC Extension Study of istaroxime in early cardiogenic shock. The study met its primary endpoint, significantly improving systolic blood pressure over six hours compared to placebo. Significant benefits were also observed in many secondary endpoints.
The study evaluated two different dose regimens of istaroxime against placebo, with infusions lasting up to 60 hours. It focused on improving low blood pressure and heart function in SCAI Stage B cardiogenic shock patients. The safety profile was favorable and consistent with previous clinical trials.
Detailed results will be presented at the Heart Failure Society of America Meeting on September 30, 2024. Windtree plans to issue a press release with more detailed results and conduct an investor call following the presentation.
Windtree Therapeutics (NasdaqCM: WINT) ha annunciato risultati positivi preliminari dal suo studio di estensione di Fase 2b SEISMiC sull'istaroxime nel trattamento dello shock cardiogeno precoce. Lo studio ha raggiunto il punto finale primario, migliorando significativamente la pressione sanguigna sistolica nel corso di sei ore rispetto al placebo. Sono stati osservati benefici significativi anche in molti punti finali secondari.
Lo studio ha valutato due diversi regimi di dosaggio dell'istaroxime rispetto al placebo, con infusioni che duravano fino a 60 ore. Si è concentrato sul miglioramento della bassa pressione sanguigna e della funzionalità cardiaca nei pazienti con shock cardiogeno in stadio B secondo SCAI. Il profilo di sicurezza è stato favorevole e coerente con precedenti studi clinici.
I risultati dettagliati saranno presentati al Meeting della Heart Failure Society of America il 30 settembre 2024. Windtree prevede di emettere un comunicato stampa con risultati più dettagliati e di condurre una call con gli investitori dopo la presentazione.
Windtree Therapeutics (NasdaqCM: WINT) anunció resultados positivos preliminares de su estudio de extensión de Fase 2b SEISMiC sobre el istaroxime en pacientes con choque cardiogénico temprano. El estudio cumplió con su punto final primario, mejorando significativamente la presión arterial sistólica durante seis horas en comparación con el placebo. También se observaron beneficios significativos en muchos puntos finales secundarios.
El estudio evaluó dos diferentes regímenes de dosis de istaroxime en comparación con el placebo, con infusiones que duraban hasta 60 horas. Se centró en mejorar la baja presión arterial y la función cardíaca en pacientes con choque cardiogénico en etapa B según SCAI. El perfil de seguridad fue favorable y consistente con ensayos clínicos previos.
Los resultados detallados se presentarán en el Congreso de la Heart Failure Society of America el 30 de septiembre de 2024. Windtree planea emitir un comunicado de prensa con más resultados detallados y realizar una llamada a los inversores después de la presentación.
Windtree Therapeutics (NasdaqCM: WINT)는 조기 심인성 쇼크에서 이스타록심에 대한 2b 단계 SEISMiC 확장 연구의 긍정적인 성과를 발표했습니다. 이 연구는 주요 목표를 달성했으며, 위약과 비교하여 6시간 동안 수축기 혈압을 상당히 개선했습니다. 많은 보조 목표에서도 상당한 혜택이 관찰되었습니다.
이 연구는 위약에 대비하여 이스타록심의 두 가지 다른 용량 요법을 평가했으며, 주입은 최대 60시간까지 지속되었습니다. SCAI B 단계의 심인성 쇼크 환자의 저혈압 및 심장 기능 개선에 중점을 두었습니다. 안전성 프로파일은 유리하고 이전 임상 시험과 일치했습니다.
자세한 결과는 2024년 9월 30일 미국 심부전 학회에서 발표될 예정입니다. Windtree는 프레스 릴리스를 통해 더 자세한 결과를 발표하고 발표 후 투자자 전화를 실시할 계획입니다.
Windtree Therapeutics (NasdaqCM: WINT) a annoncé des résultats préliminaires positifs de son étude d'extension de Phase 2b SEISMiC sur l'istaroxime dans le traitement du choc cardiogène précoce. L'étude a atteint son objectif principal, en améliorant significativement la pression artérielle systolique sur six heures par rapport au placebo. Des bénéfices significatifs ont également été observés dans de nombreux critères secondaires.
L'étude a évalué deux schémas posologiques différents de l'istaroxime par rapport au placebo, avec des infusions durant jusqu'à 60 heures. Elle s'est concentrée sur l'amélioration de l'hypotension et de la fonction cardiaque chez les patients en choc cardiogène au stade B selon la classification SCAI. Le profil de sécurité s'est avéré favorable et cohérent avec les études cliniques précédentes.
Les résultats détaillés seront présentés lors de la réunion de la Heart Failure Society of America le 30 septembre 2024. Windtree prévoit de publier un communiqué de presse avec des résultats plus détaillés et d’organiser une conférence téléphonique pour les investisseurs suite à la présentation.
Windtree Therapeutics (NasdaqCM: WINT) hat positive vorläufige Ergebnisse aus seiner Phase 2b SEISMiC Erweiterungsstudie zu Istaroxim bei frühem kardiogenem Schock bekannt gegeben. Die Studie erreichte ihr primäres Endziel und verbesserte den systolischen Blutdruck über einen Zeitraum von sechs Stunden signifikant im Vergleich zur Placebo-Gruppe. Auch in vielen sekundären Endpunkten wurden signifikante Vorteile beobachtet.
Die Studie bewertete zwei verschiedene Dosierungsregime von Istaroxim im Vergleich zu Placebo, wobei die Infusionen bis zu 60 Stunden dauerten. Der Fokus lag auf der Verbesserung des niedrigen Blutdrucks und der Herzfunktion bei kardiogenem Schock der SCAI-Stufe B. Das Sicherheitsprofil war günstig und stimmte mit früheren klinischen Studien überein.
Detailierte Ergebnisse werden auf dem Meeting der Heart Failure Society of America am 30. September 2024 veröffentlicht. Windtree plant, eine Pressemitteilung mit detaillierteren Ergebnissen herauszugeben und nach der Präsentation eine Investorenkonferenz abzuhalten.
- Met primary endpoint of significantly improving systolic blood pressure over six hours
- Significant benefits observed in many secondary endpoints
- Favorable safety profile consistent with previous clinical trials
- Extended dosing duration of up to 60 hours compared to previous 24-hour studies
- No association with increased cardiac arrhythmias, potentially differentiating from current therapies
- None.
Insights
The Phase 2b SEISMiC Extension Study results for istaroxime in early cardiogenic shock are highly promising. The study met its primary endpoint of significantly improving systolic blood pressure over six hours, a important clinical objective for patients with SCAI Stage B cardiogenic shock. This is a substantial advancement in the treatment of this critical condition, which currently has effective therapies.
Key points to consider:
- The study expanded on previous positive Phase 2 results, now testing extended dosing durations up to 60 hours
- Two dosing regimens were evaluated: decreasing dose over time and constant dose
- Secondary endpoints also showed significant benefits
- The safety profile was favorable and consistent with previous trials
- Importantly, istaroxime has not been associated with increased cardiac arrhythmias, potentially differentiating it from current therapies
This data positions istaroxime well for progression to Phase 3 trials. The upcoming detailed presentation at the Heart Failure Society of America Meeting will be important for understanding the full potential of this drug candidate.
The positive topline results from Windtree's Phase 2b study are a significant milestone for the company, potentially increasing its value proposition for investors. Key financial implications include:
- Increased probability of advancing to Phase 3, potentially attracting partnership or licensing opportunities
- Potential market expansion in the lucrative cardiogenic shock treatment space, estimated to be worth
$1.25 billion globally by 2027 - Possible increase in investor interest and stock price, given the positive clinical data
- Potential for future revenue streams if istaroxime reaches commercialization
However, investors should note that Windtree is a small-cap company (
Istaroxime significantly improved primary endpoint of the systolic blood pressure profile over six hours and showed significant improvements in many secondary endpoint assessments
Study results to be presented at the Heart Failure Society of America Medical Conference on September 30, 2024
WARRINGTON, Pa., Sept. 25, 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 positive topline results from its Phase 2b SEISMiC Extension Study of istaroxime in significantly increasing systolic blood pressure over six hours, a critical clinical objective in treating patients in early cardiogenic shock due to heart failure.
The SEISMiC Extension Study in early cardiogenic shock (SCAI Stage B) is being conducted in the United States, Europe and Latin America. The study is focused on the effects of istaroxime on blood pressure, cardiac function and other parameters over 96 hours of close monitoring with the final visit at 30 days. The results build upon the positive results reported previously in the Phase 2 SEISMiC trial. The SEISMiC Extension Study focused on improving low blood pressure and heart function and providing other potential benefits in early cardiogenic shock patients. It also provided information to help further inform dose optimization and the characterization of istaroxime’s mechanism of action including potential benefits of SERCA2a activation. The study included hospitalized patients with SCAI Stage B cardiogenic shock with persistent hypotension due to acute heart failure and evaluated two different dose regimens of istaroxime compared to placebo. Patients received infusions of istaroxime for up to 60 hours, with one group receiving a decreasing istaroxime dose over time and the second group receiving a constant istaroxime dose. The study tested an extended dosing duration of istaroxime compared to previous studies where treatment was limited to 24 hours to determine the potential for additional benefit and, along with dose titration, is an important factor in determining the optimal dosing regimen to utilize in a late-stage trial. Importantly, the study collected detailed information related to both cardiac and renal function and additional safety information on cardiac arrhythmias. Istaroxime has not been associated with an increase in cardiac arrhythmias, which the Company believes is a potentially important differentiating characteristic compared to commonly used current drug therapies.
Topline study results:
- The study met its primary endpoint in significantly improving systolic blood pressure over six hours, with the combined istaroxime group performing significantly better compared to the placebo group. Significant benefits were seen in many secondary endpoints as well.
- The safety profile was favorable and generally consistent with what has been previously reported in other clinical trials.
- Further details of study results, including other measures of efficacy and safety and by individual istaroxime dosing groups, are planned to be presented at the Heart Failure Society of America Meeting on September 30, 2024.
- Following the clinical presentation at the conference, the Company plans to issue a press release with more detailed results as well as conduct an investor call (details of which to follow in the coming days).
Dr. Steve Simonson, Senior Vice President and Chief Medical Officer at Windtree said, “We are very pleased with the results of the study and the potential for istaroxime to positively impact patients in acute heart failure with early cardiogenic shock. The study collected a large amount of data related to blood pressure profiles, cardiac function and safety measures for two istaroxime dosing regimens. We look forward to sharing more details at the Heart Failure Society of America Meeting and through a presentation of the data.”
Craig Fraser, Chairman and CEO of Windtree stated, “Cardiogenic shock is a critical condition with high morbidity and mortality where clinicians note a high need for new drug innovation. Across four Phase 2 studies to date, istaroxime has demonstrated a highly unique and attractive profile as a potential therapy for cardiogenic shock and acute heart failure patients. We are excited to share the details of study results next week and to continuing to progress istaroxime towards Phase 3 readiness for 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 improved 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; 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 Israel and Gaza, 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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