Windtree Completes Enrollment of Phase 2b Study of Istaroxime in Early Cardiogenic Shock
Windtree Therapeutics (NASDAQ: WINT) has completed enrollment in its SEISMiC Extension Phase 2b study of istaroxime for early cardiogenic shock caused by heart failure. The study aims to extend positive results from a previous Phase 2 trial, evaluating istaroxime's ability to improve heart function and blood pressure. The trial includes longer dosing duration and dose tapering, with topline data expected in late September 2024.
Istaroxime is a novel first-in-class therapy that has shown promise in three Phase 2 trials for acute heart failure. The global cardiogenic shock market is estimated at $1.25 billion annually. The study, conducted in the U.S., Europe, and Latin America, focuses on dose optimization and further characterization of istaroxime's SERCA2a mechanism in early cardiogenic shock patients.
Windtree Therapeutics (NASDAQ: WINT) ha completato l'arruolamento nel suo studio SEISMiC Extension Phase 2b su istaroxime per shock cardiogeno precoce causato da insufficienza cardiaca. Lo studio mira a estendere i risultati positivi di un precedente trial di Fase 2, valutando la capacità di istaroxime di migliorare la funzione cardiaca e la pressione sanguigna. Il trial prevede una durata di dosaggio più lunga e una riduzione progressiva della dose, con i dati principali attesi per la fine di settembre 2024.
Istaroxime è una nuova terapia di prima classe che ha mostrato promessa in tre trial di Fase 2 per insufficienza cardiaca acuta. Il mercato globale dello shock cardiogeno è stimato in 1,25 miliardi di dollari all'anno. Lo studio, condotto negli Stati Uniti, in Europa e in America Latina, si concentra sull'ottimizzazione della dose e su una caratterizzazione ulteriore del meccanismo SERCA2a di istaroxime nei pazienti con shock cardiogeno precoce.
Windtree Therapeutics (NASDAQ: WINT) ha completado la inscripción en su estudio SEISMiC Extension Phase 2b de istaroxime para el shock cardiogénico temprano causado por insuficiencia cardíaca. El estudio tiene como objetivo extender los resultados positivos de un ensayo previo de Fase 2, evaluando la capacidad de istaroxime para mejorar la función cardíaca y la presión arterial. El ensayo incluye una duración de dosificación más larga y una reducción gradual de la dosis, con los datos principales esperados para finales de septiembre de 2024.
Istaroxime es una terapia novedosa de primera clase que ha mostrado promesas en tres ensayos de Fase 2 para la insuficiencia cardíaca aguda. Se estima que el mercado global del shock cardiogénico es de 1.25 mil millones de dólares anuales. El estudio, llevado a cabo en EE.UU., Europa y América Latina, se centra en la optimización de la dosis y en la caracterización adicional del mecanismo SERCA2a de istaroxime en pacientes con shock cardiogénico temprano.
Windtree Therapeutics (NASDAQ: WINT)는 등록 완료를 발표했습니다. 이는 심부전으로 인한 조기 심인성 쇼크를 위한 이스타록심의 SEISMiC Extension Phase 2b 연구입니다. 이 연구는 이전 2상 시험의 긍정적인 결과를 연장하고 이스타록심이 심장 기능 및 혈압 개선에 미치는 능력을 평가하는 것을 목표로 합니다. 이 시험은 더 긴 투여 기간과 용량 점차 감소를 포함하며, 주요 데이터는 2024년 9월 말에 발표될 예정입니다.
이스타록심은 급성 심부전 치료를 위한 2상 시험에서 가능성을 보여준 새로운 1군 요법입니다. 전 세계 심인성 쇼크 시장은 연간 12억 5천만 달러로 추정됩니다. 미국, 유럽 및 라틴 아메리카에서 진행되는 이 연구는 조절된 투여량 최적화와 조기 심인성 쇼크 환자에서 이스타록심의 SERCA2a 메커니즘에 대한 추가 특성화를 중심으로 합니다.
Windtree Therapeutics (NASDAQ: WINT) a achevé le recrutement dans son étude SEISMiC Extension Phase 2b sur istaroxime pour le choc cardiogène précoce causé par l'insuffisance cardiaque. L'étude vise à étendre les résultats positifs d'un précédent essai de Phase 2, en évaluant la capacité de l'istaroxime à améliorer la fonction cardiaque et la pression artérielle. L'essai comprend une durée de dosages plus longue et un ajustement progressif de la dose, avec des données préliminaires attendues pour fin septembre 2024.
L'istaroxime est une nouvelle thérapie de première classe qui a montré des promesses dans trois essais de Phase 2 pour l'insuffisance cardiaque aiguë. Le marché mondial du choc cardiogène est estimé à 1,25 milliard de dollars par an. L'étude, menée aux États-Unis, en Europe et en Amérique latine, se concentre sur l'optimisation des doses et la caractérisation supplémentaire du mécanisme SERCA2a de l'istaroxime chez les patients souffrant de choc cardiogène précoce.
Windtree Therapeutics (NASDAQ: WINT) hat die Einschreibung abgeschlossen für seine SEISMiC Extension Phase 2b Studie zu istaroxime bei frühem kardio-genem Schock aufgrund von Herzinsuffizienz. Die Studie zielt darauf ab, positive Ergebnisse einer vorherigen Phase 2-Studie zu erweitern, indem die Fähigkeit von istaroxime zur Verbesserung der Herzfunktion und des Blutdrucks bewertet wird. Die Studie umfasst eine längere Dosierungsdauer und eine Dosisanpassung, wobei die wichtigsten Daten für Ende September 2024 erwartet werden.
Istaroxime ist eine neuartige Therapie der ersten Klasse, die in drei Phase 2-Studien bei akuter Herzinsuffizienz vielversprechend war. Der globale Markt für kardio-genen Schock wird auf 1,25 Milliarden Dollar jährlich geschätzt. Die in den USA, Europa und Lateinamerika durchgeführte Studie konzentriert sich auf die Dosisoptimierung und die weitere Charakterisierung des SERCA2a-Mechanismus von istaroxime bei Patienten mit frühem kardio-genem Schock.
- Completed enrollment in Phase 2b study for istaroxime in early cardiogenic shock
- Positive results from previous Phase 2 trials in improving heart function and blood pressure
- Potential to address a $1.25 billion annual global market for cardiogenic shock
- Istaroxime has not been associated with increased cardiac arrhythmias, a potential differentiator from current therapies
- Topline data not available until late September 2024
- Still in Phase 2b, indicating more studies may be needed before potential market approval
Insights
The completion of enrollment in Windtree's Phase 2b SEISMiC Extension study for istaroxime in early cardiogenic shock is a significant milestone. This study builds upon previous positive results and aims to optimize dosing strategies. Key points:
- Extended dosing duration (up to 60 hours) and dose tapering could potentially enhance efficacy
- Focus on cardiac function and safety, particularly arrhythmia risk
- Istaroxime's unique SERCA2a mechanism may offer advantages over current therapies
The study's design, targeting SCAI Stage B patients, is strategically important for positioning istaroxime in the treatment paradigm. If successful, this could address a critical unmet need in early cardiogenic shock management, potentially reducing progression to more severe stages.
Windtree's progress with istaroxime has positive implications for the company's market position:
- Cardiogenic shock market estimated at
$1.25 billion annually - Potential first-in-class therapy addressing limitations of current treatments
- Positive Phase 2 results in three trials suggest a strong foundation
The upcoming topline data in September 2024 will be a critical catalyst for Windtree's stock. Positive results could significantly enhance the company's value proposition, especially given the lack of satisfactory pharmacological interventions in this space. However, investors should be aware that Phase 2b success doesn't guarantee Phase 3 outcomes or eventual FDA approval.
Topline data anticipated in late September 2024
WARRINGTON, Pa., Sept. 04, 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 it has successfully completed enrollment in its SEISMiC Extension Phase 2b study of istaroxime in early cardiogenic shock caused by heart failure. The study is evaluating the ability of istaroxime to improve heart function and low blood pressure in the setting of early cardiogenic shock due to heart failure. The Company is looking to extend the positive results on these parameters as observed in the Company’s first SEISMiC Phase 2 clinical study that was previously reported. In addition, the Company hopes that the study results will substantiate the encouraging observations from the Company’s Phase 2 clinical study, indicating istaroxime has a favorable renal profile and does not increase cardiac arrhythmias. The SEISMiC Extension Study is utilizing longer dosing duration and tapering the dosing to assess the potential benefits.
Istaroxime is a novel first-in-class therapy that has demonstrated the ability to improve systolic contraction and diastolic relaxation of the heart while also increasing blood pressure and maintaining or improving renal function in patients with compromised cardiac function in three positive Phase 2 trials enrolling patients with acute heart failure (AHF). Cardiogenic shock is a serious condition that can occur when AHF patients continue to deteriorate and the heart cannot pump enough blood and oxygen to the brain, kidneys, and other vital organs. Mortality rates are significant and, depending on severity, range from
The SEISMiC Extension Study in cardiogenic shock was conducted in the U.S., Europe and Latin America and is expected to build upon the positive results from the Company’s first SEISMiC Phase 2 clinical study. The SEISMiC Extension Study is focused on dose optimization and additional characterization of istaroxime’s novel SERCA2a mechanism and its potential benefits in cardiogenic shock patients. The study includes hospitalized patients with early cardiogenic shock (SCAI Stage B) due to AHF and evaluates 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. This study has extended the istaroxime dosing duration compared to previous studies where treatment was limited to 24 hours and has the potential to provide additional benefit and, along with dose titration, is an important factor in determining the optimal dosing regimen to utilize in a late-stage trial. The study is also collecting detailed information related to cardiac 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.
“Completing enrollment in the SEISMiC Extension Study is an important step in advancing the istaroxime program to Phase 3, along with the ongoing SEISMiC C study in more severe cardiogenic shock patients” said Steve Simonson, MD, Chief Medical Officer and Senior Vice President of Windtree. “We look forward to announcing topline results from the SEISMiC Extension Study by the end of the month and plan to present this data at a major medical meeting in the very near future.”
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 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
FAQ
What is the purpose of Windtree's SEISMiC Extension Phase 2b study for istaroxime (WINT)?
When are the topline results expected for Windtree's istaroxime study (WINT)?
What is the estimated market value for cardiogenic shock treatments that Windtree's istaroxime (WINT) is targeting?
How does istaroxime (WINT) potentially differ from current cardiogenic shock treatments?
