WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) announced the United States Patent and Trademark Office (USPTO) recently issued a Notice of Allowance of new patent claims for istaroxime administration. A notice of allowance is issued by the USPTO to indicate that the application has passed examination. When the patent is issued by the USPTO in the near future, it will provide new intellectual property protection for istaroxime until late 2039.
The istaroxime patent application is entitled, “Istaroxime-Containing Intravenous Formulation for the Treatment of Acute Heart Failure (AHF),” and was the result of an expedited US Track One filing by Windtree in April 2021. The claims cover longer infusion durations of istaroxime for improved outcomes in treatment of acute heart failure. Istaroxime is an investigational drug candidate being studied in acute heart failure and also in early cardiogenic shock. Phase 2a and Phase 2b studies in acute heart failure have demonstrated significant improvements in cardiac function as well as preserving or increasing blood pressure and renal function.
“We continue to strengthen the istaroxime patent estate and look forward to the anticipated issuance of this patent from the USPTO,” said Craig Fraser, President and CEO of Windtree Therapeutics. “The istaroxime patent estate is a priority for Windtree and we plan to add additional elements to it as data is obtained in our clinical studies.”
Windtree plans to start the next acute heart failure study by mid-2022. This study will target AHF patients with normal to low blood pressure and look to optimize istaroxime dosing by employing a longer infusion duration. The primary endpoint will be echocardiographic assessment of cardiac function (similar to the 2b study). It will also include as secondary endpoints, assessments that could potentially become primary pivotal endpoints in the Phase 3 program and thus put the program in what the company believes will be a good Phase 3 ready and partnership position. In the meantime, the company is also conducting a Phase 2 study in early cardiogenic shock patients with results expected in the first quarter of 2022.
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