Windtree Announces Special Late-Breaking Clinical Science Abstract Presentation on Istaroxime at the Technology and Heart Failure Therapeutics Conference
Windtree Therapeutics (WINT) announced a presentation of their istaroxime Phase 2b SEISMiC study at the Technology and Heart Failure Therapeutics Conference in Boston. The presentation, given by Dr. Matteo Pagnesi on February 11, 2025, focused on the drug's hemodynamic effects in patients with SCAI Stage B cardiogenic shock.
Istaroxime, a first-in-class investigational therapy, aims to improve cardiac function and increase blood pressure in early cardiogenic shock patients. The drug has shown positive results in four Phase 2 trials, demonstrating favorable safety profile and no detrimental effects on renal function. The company has prioritized cardiogenic shock as an initial indication target due to substantial unmet medical needs, as current treatments often have unwanted side effects and poor outcomes.
Windtree Therapeutics (WINT) ha annunciato una presentazione del loro studio SEISMiC di Fase 2b su istaroxime alla Conferenza sulla Tecnologia e le Terapie per l'Insufficienza Cardiaca a Boston. La presentazione, tenuta dal Dr. Matteo Pagnesi l'11 febbraio 2025, si è concentrata sugli effetti emodinamici del farmaco nei pazienti con shock cardiogeno di stadio B secondo SCAI.
Istaroxime, una terapia sperimentale di prima classe, mira a migliorare la funzione cardiaca e aumentare la pressione sanguigna nei pazienti con shock cardiogeno precoce. Il farmaco ha mostrato risultati positivi in quattro studi di Fase 2, dimostrando un profilo di sicurezza favorevole e nessun effetto negativo sulla funzione renale. L'azienda ha prioritizzato lo shock cardiogeno come obiettivo iniziale a causa delle significative esigenze mediche insoddisfatte, poiché i trattamenti attuali spesso presentano effetti collaterali indesiderati e scarsi risultati.
Windtree Therapeutics (WINT) anunció una presentación de su estudio SEISMiC de Fase 2b sobre istaroxime en la Conferencia de Tecnología y Terapias para la Insuficiencia Cardíaca en Boston. La presentación, realizada por el Dr. Matteo Pagnesi el 11 de febrero de 2025, se centró en los efectos hemodinámicos del fármaco en pacientes con shock cardiogénico de etapa B según SCAI.
Istaroxime, una terapia en investigación de primera clase, tiene como objetivo mejorar la función cardíaca y aumentar la presión arterial en pacientes con shock cardiogénico temprano. El fármaco ha mostrado resultados positivos en cuatro ensayos de Fase 2, demostrando un perfil de seguridad favorable y sin efectos perjudiciales en la función renal. La empresa ha priorizado el shock cardiogénico como un objetivo inicial debido a las importantes necesidades médicas insatisfechas, ya que los tratamientos actuales a menudo tienen efectos secundarios no deseados y malos resultados.
Windtree Therapeutics (WINT)는 보스턴에서 열린 기술 및 심부전 치료 회의에서 istaroxime 2b상 SEISMiC 연구에 대한 발표를 했다고 발표했습니다. 2025년 2월 11일 Matteo Pagnesi 박사가 발표한 이 내용은 SCAI B단계 심인성 쇼크 환자에서 약물의 혈역학적 효과에 초점을 맞췄습니다.
Istaroxime은 1세대 임상 연구 치료제로, 초기 심인성 쇼크 환자의 심장 기능을 개선하고 혈압을 증가시키는 것을 목표로 합니다. 이 약물은 4개의 2상 시험에서 긍정적인 결과를 보여주었으며, 안전성 프로필이 우수하고 신장 기능에 해로운 영향을 미치지 않는 것으로 나타났습니다. 회사는 현재 치료법이 종종 원치 않는 부작용과 나쁜 결과를 초래하기 때문에 심인성 쇼크를 초기 적응증 대상으로 우선시했습니다.
Windtree Therapeutics (WINT) a annoncé une présentation de leur étude SEISMiC de Phase 2b sur l'istaroxime lors de la Conférence sur la Technologie et les Thérapies de l'Insuffisance Cardiaque à Boston. La présentation, faite par le Dr Matteo Pagnesi le 11 février 2025, s'est concentrée sur les effets hémodynamiques du médicament chez les patients présentant un choc cardiogénique de stade B selon SCAI.
L'istaroxime, une thérapie expérimentale de première classe, vise à améliorer la fonction cardiaque et à augmenter la pression artérielle chez les patients présentant un choc cardiogénique précoce. Le médicament a montré des résultats positifs dans quatre essais de Phase 2, démontrant un profil de sécurité favorable et aucun effet néfaste sur la fonction rénale. L'entreprise a donné la priorité au choc cardiogénique comme indication initiale en raison des besoins médicaux non satisfaits importants, car les traitements actuels présentent souvent des effets secondaires indésirables et de mauvais résultats.
Windtree Therapeutics (WINT) gab eine Präsentation ihrer istaroxime Phase 2b SEISMiC-Studie auf der Konferenz für Technologie und Herzinsuffizienztherapien in Boston bekannt. Die Präsentation, gehalten von Dr. Matteo Pagnesi am 11. Februar 2025, konzentrierte sich auf die hämodynamischen Effekte des Medikaments bei Patienten mit SCAI Stadium B kardiogenem Schock.
Istaroxime, eine erstklassige experimentelle Therapie, zielt darauf ab, die Herzfunktion zu verbessern und den Blutdruck bei Patienten mit frühem kardiogenem Schock zu erhöhen. Das Medikament hat in vier Phase 2-Studien positive Ergebnisse gezeigt, mit einem günstigen Sicherheitsprofil und keinen nachteiligen Auswirkungen auf die Nierenfunktion. Das Unternehmen hat kardiogenen Schock als anfängliches Ziel priorisiert, da es erhebliche ungedeckte medizinische Bedürfnisse gibt, da die aktuellen Behandlungen oft unerwünschte Nebenwirkungen und schlechte Ergebnisse haben.
- Completed four positive Phase 2 trials for istaroxime
- Drug demonstrates favorable safety profile with no renal function impact
- Addresses substantial unmet medical need in cardiogenic shock treatment
- Still in early development phase, requiring Phase 3 trials before potential approval
- Faces competition from existing treatments in the market
Insights
The presentation of istaroxime's Phase 2b SEISMiC study results at the Technology and Heart Failure Therapeutics Conference underscores the drug's potential in addressing a critical unmet need in cardiogenic shock treatment. The current standard of care for SCAI Stage B cardiogenic shock relies on medications that often come with significant drawbacks, including organ dysfunction and poor patient outcomes.
The key differentiator for istaroxime lies in its novel dual mechanism of action. While existing treatments often require careful balancing of benefits against risks to kidney function, istaroxime has demonstrated the ability to improve cardiac function and blood pressure without compromising renal health - a important advantage in this patient population. The completion of four positive Phase 2 trials provides robust validation of this safety and efficacy profile.
From a development perspective, Windtree's focus on early cardiogenic shock as the initial indication represents a strategic approach to market entry. The cardiogenic shock market, while relatively specialized, represents a high-value opportunity due to the lack of effective treatments and high mortality rates. The continued interest from cardiologists globally suggests potential strong adoption if the drug reaches market approval.
However, investors should note that while the conference presentation maintains visibility for the program, the critical value-driving catalysts will come with the initiation of Phase 3 trials and subsequent regulatory milestones. The path to commercialization still requires significant clinical validation through larger-scale studies.
WARRINGTON, Pa., Feb. 12, 2025 (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, announced that an istaroxime presentation featuring the positive Phase 2b SEISMiC study was given on February 11, 2025 at the Technology and Heart Failure Therapeutics Conference in Boston, MA.
Matteo Pagnesi, MD, PhD a cardiologist from Spedali Civili di Brescia, Italy gave the presentation entitled, “Hemodynamic Effects of Intravenous Istaroxime in Patients With SCAI Stage B Cardiogenic Shock: Insights From the SEISMiC Trial.”
Early (SCAI Stage B) cardiogenic shock is characterized by low blood pressure, leaving the patient at risk of developing inadequate blood flow to vital organs leading to high morbidity and mortality. Istaroxime is a novel first-in-class investigational therapy that is intended to improve cardiac function and increase blood pressure to reverse the condition. Istaroxime produces these effects without detrimental effects on renal function and has a generally favorable safety profile. Istaroxime has been studied in four positive Phase 2 trials enrolling subjects with early cardiogenic shock due to acute heart failure.
“We continue to see interest in istaroxime from cardiologists around the world in treating cardiogenic shock,” said Dr. Steve Simonson, CMO and SVP of Windtree. “Windtree has prioritized cardiogenic shock as an initial indication target because of the unique profile of istaroxime effects and the positive Phase 2 studies in early cardiogenic shock. There is substantial unmet need for this patient population as currently available drugs can have unwanted side effects and poor outcomes. We are encouraged by the profile of istaroxime and look forward to progressing istaroxime toward Phase 3 in 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 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 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 forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including statements related to the potential clinical effects of istaroxime; the potential benefits and safety of istaroxime; the clinical development of istaroxime; and our research and development program for treating patients in early cardiogenic shock due to heart failure. 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 secure and successfully complete an out-licensing or asset acquisition transaction; 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 the Middle East, 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:
Windtree:
Eric Curtis
ecurtis@windtreetx.com
FAQ
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