Windtree announces U.S. patent and registered trademark

WARRINGTON, Pa., Dec. 15, 2021 (GLOBE NEWSWIRE) – Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing several advanced stage interventions for acute cardiovascular and pulmonary disorders, announced today The United States State Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,197,869, covering intravenous administration of istaroxime for the treatment of acute heart failure.

The US patent, entitled: “Intravenous formulation containing istaroxime for the treatment of acute heart failure (AHF), ”Covers longer infusion times of istaroxime for better results in the treatment of acute heart failure. In particular, the patent refers to results of improvement of at least one echocardiographic indicator of diastolic function, which Windtree attributes to the SERCA2a mechanism of action of istaroxime and its metabolites. Istaroxime is an investigational drug candidate being investigated in acute heart failure and early cardiogenic shock. Phase 2a and Phase 2b studies in acute heart failure demonstrated significant improvements in heart function as well as preservation or increase in blood pressure and kidney function and received the Fast Track designation from the FDA for acute heart failure.

“Given the multiple development projects and programs that we are advancing with istaroxime, we are delighted that this patent contributes to the protection of the intellectual property of istaroxime,” said Craig Fraser, CEO and President. “We plan to continue to pursue and develop the IP field around istaroxime as additional data is obtained in our clinical studies, including the current early cardiogenic shock study with the first results expected in the first quarter of 2022. as well as our next study on acute heart failure. “

About Istaroxime
Istaroxime is a first-class dual mechanism therapy designed to improve both systolic and diastolic heart function. Istaroxime is a positive inotropic agent that increases myocardial contractility by inhibiting Na + / K + -ATPase with a complementary mechanism that facilitates myocardial relaxation by activating the SERCA2a calcium pump on the sarcoplasmic reticulum improving calcium reuptake of the cytoplasm. Data from several phase 2 studies in patients with acute heart failure (AHF) show that intravenously infused istaroxime significantly improves heart function and blood pressure without causing increased heart rate or disturbances. rhythm.

About Windtree Therapeutics
Windtree Therapeutics, Inc. offers several advanced stage interventions for acute cardiovascular and pulmonary disorders to treat patients in times of crisis. Using new scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds capable of activating SERCA2a, with lead candidate istaroxime in development as a premier treatment for acute heart failure and for early cardiogenic shock. Windtree’s heart failure platform also includes pre-clinical oral follow-up SERCA2a activator assets. In pulmonary care, Windtree focused on facilitating the transfer of AEROSURF clinical development® to its licensee in Asia, Lee’s HK. Windtree is also evaluating surfactant KL4 for the treatment of acute respiratory distress syndrome in COVID-19 patients. Windtree’s portfolio includes rostafuroxin, a new precision drug targeting hypertensive patients with certain genetic profiles.

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 certain circumstances, use terms such as “predict”, “believe”, “potential”, “proposed”, “ continue “,” estimate “,” plan “,” expect “,” plan “,” intend “,” could “,” could “,” could “,” will “,” should “or other words which reflect the uncertainty of future events or results to identify these forward-looking statements. These statements are based on information available to the Company at the date of this press release and are subject to numerous factors, risks and significant uncertainties that may cause actual events or results to differ materially from the Company’s current expectations. Examples of such risks and uncertainties include: risks and uncertainties associated with the ongoing economic and social consequences of the COVID pandemic -1 9, including any negative impact on the Company’s clinical trials, clinical trial timelines or supply chain disruptions; the success and advancement of clinical development programs for istaroxime, surfactant KL4 and the Company’s other product candidates; the Company’s ability to raise significant additional capital as and when required; the Company’s ability to access the debt or equity markets; the Company’s ability to manage costs and execute its operational and budgetary plans; the results, costs and timing of the Company’s clinical development programs, including any delay in these clinical trials related to recruitment or site initiation; risks associated with technology transfers to contract manufacturers and manufacturing development activities; delays experienced by the Company, contract manufacturers or suppliers in manufacturing drug products, drug substances, aerosol delivery systems (ADS) and other materials in a timely manner and in sufficient quantities; risks associated with stringent regulatory requirements, including: (i) the FDA or other regulatory authorities may disagree with the Company on issues raised during regulatory reviews, may require significant additional activities, or may not accept or may defer or delay consideration of applications, or may not approve or limit the approval of the Company’s product candidates, and (ii) changes in the domestic or international policy and regulatory environment may render more difficulty in obtaining regulatory approvals and the risks associated with the Company’s efforts to maintain and protect patents and licenses related to its product candidates; the risks that the Company will never realize the value of its intangible assets and incur future impairment charges; risks related to the size and growth potential of markets for the Company’s product candidates, and the Company’s ability to serve these markets; the Company’s ability to develop its commercial and marketing capacities, alone or with potential future employees; and the rate and degree of market acceptance of the Company’s product candidates, if approved. These and other risks are described in the periodic reports of the Company, including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed or provided to the Securities and Exchange Commission and available at www.sec.gov. All 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 any forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.

Contact details:
Monique Kossé
LifeSci Advisors
212.915.3820 or [email protected]

Media contact:
André Mielach
LifeSci Communications
646.876.5868 or [email protected]

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