Windtree Announces Issuance of Istaroxime Patent for the United States for Acute Heart Failure
Windtree Therapeutics (NASDAQ:WINT) has secured a new U.S. patent for istaroxime, its drug candidate for treating acute heart failure (AHF). The patent (application #18/150,870) covers istaroxime-containing intravenous formulation and extends protection until 2039.
The drug has already demonstrated success in two Phase 2 AHF studies and two early cardiogenic shock studies. This development is particularly significant as AHF affects 1.3 million hospitalized patients annually in the U.S. and represents the leading cause of hospitalization for patients over 65 years old.
Windtree Therapeutics (NASDAQ:WINT) ha ottenuto un nuovo brevetto negli Stati Uniti per l'istaroxime, il suo candidato farmaco per il trattamento dello scompenso cardiaco acuto (AHF). Il brevetto (domanda n. 18/150,870) riguarda una formulazione endovenosa contenente istaroxime e garantisce protezione fino al 2039.
Il farmaco ha già mostrato risultati positivi in due studi di Fase 2 sull'AHF e in due studi precoci sullo shock cardiogeno. Questo sviluppo è particolarmente importante poiché l'AHF colpisce ogni anno 1,3 milioni di pazienti ricoverati negli Stati Uniti ed è la principale causa di ospedalizzazione per i pazienti sopra i 65 anni.
Windtree Therapeutics (NASDAQ:WINT) ha obtenido una nueva patente en EE.UU. para istaroxime, su candidato a medicamento para tratar la insuficiencia cardíaca aguda (AHF). La patente (solicitud n.º 18/150,870) cubre una formulación intravenosa que contiene istaroxime y extiende la protección hasta 2039.
El medicamento ya ha demostrado éxito en dos estudios de Fase 2 sobre AHF y dos estudios iniciales sobre shock cardiogénico. Este avance es especialmente relevante ya que la AHF afecta a 1.3 millones de pacientes hospitalizados anualmente en EE.UU. y es la principal causa de hospitalización en pacientes mayores de 65 años.
Windtree Therapeutics (NASDAQ:WINT)는 급성 심부전(AHF) 치료제 후보인 이스타록심(istaroxime)에 대해 미국에서 새로운 특허를 획득했습니다. 해당 특허(출원 번호 18/150,870)는 이스타록심이 포함된 정맥 주사용 제형을 보호하며, 보호 기간은 2039년까지 연장됩니다.
이 약물은 이미 두 건의 2상 급성 심부전 연구와 두 건의 초기 심인성 쇼크 연구에서 성공을 입증했습니다. 이 발전은 미국에서 매년 130만 명의 입원 환자에게 영향을 미치며 65세 이상 환자의 주요 입원 원인인 급성 심부전이라는 점에서 특히 중요합니다.
Windtree Therapeutics (NASDAQ:WINT) a obtenu un nouveau brevet américain pour l'istaroxime, son candidat-médicament destiné au traitement de l'insuffisance cardiaque aiguë (AHF). Le brevet (demande n° 18/150,870) couvre une formulation intraveineuse contenant l'istaroxime et prolonge la protection jusqu'en 2039.
Le médicament a déjà démontré son efficacité lors de deux études de phase 2 sur l'AHF et deux études précoces sur le choc cardiogénique. Ce développement est particulièrement important car l'AHF touche 1,3 million de patients hospitalisés chaque année aux États-Unis et constitue la principale cause d'hospitalisation chez les patients de plus de 65 ans.
Windtree Therapeutics (NASDAQ:WINT) hat ein neues US-Patent für Istaroxim erhalten, seinen Arzneimittelkandidaten zur Behandlung von akuter Herzinsuffizienz (AHF). Das Patent (Anmeldung Nr. 18/150.870) umfasst eine intravenöse Formulierung mit Istaroxim und verlängert den Schutz bis 2039.
Das Medikament hat bereits Erfolge in zwei Phase-2-Studien zur AHF und zwei frühen Studien zum kardiogenen Schock gezeigt. Diese Entwicklung ist besonders bedeutsam, da AHF in den USA jährlich 1,3 Millionen hospitalisierte Patienten betrifft und die Hauptursache für Krankenhausaufenthalte bei Patienten über 65 Jahren darstellt.
- None.
- Phase 3 trials not yet initiated
- FDA approval still pending with no guaranteed timeline
1.3 million patients are hospitalized annually in the U.S. from acute heart failure and it is the #1 cause of hospitalization in patients >65 years old
If istaroxime is approved in the US for acute heart failure, this patent would provide protection to 2039
WARRINGTON, Pa., July 02, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a diversified company focused on revenue generation in multiple growing industries is pleased to announce that the United States Patent and Trademark Office has issued an istaroxime patent for the United States - application number 18/150,870 directed to “ISTAROXIME-CONTAINING INTRAVENOUS FORMULATION FOR THE TREATMENT OF ACUTE HEART FAILURE.”
Acute heart failure, or AHF, impacts millions of patients globally and istaroxime has previously completed two positive Phase 2 AHF studies and two positive early cardiogenic shock studies caused by acute heart failure.
“We are pleased to strengthen our intellectual property for istaroxime with this patent for the United States,” said Jed Latkin, CEO of Windtree. “Istaroxime is approaching Phase 3 readiness in cardiogenic shock and acute heart failure. If istaroxime is approved in AHF, this patent would provide protection until 2039. We believe the profile of istaroxime is differentiated from currently available drugs and drug treatment innovation is desired for patients.”
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 focused on becoming a revenue generating company in a multitude of growing industries to drive toward overall profitability.
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 Company’s risks and uncertainties associated with the success and advancement of its product candidates; the Company’s ability to manage costs and execute on its operational and budget plans; 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 regulatory requirements; 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 impacts of political unrest, including as a result of geopolitical tension, 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. 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
