Windtree Announces Notice of Allowance from the US Patent and Trademark Office for a New Istaroxime Patent

Windtree Therapeutics

WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) reported that 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.

Istaroxime is an investigational drug candidate being studied in early cardiogenic shock and acute heart failure. It has a novel dual mechanism of action that increases both systolic contraction and diastolic relaxation (the latter by uniquely addressing heart failure associated SERCA2a dysfunction). SERCA2a activation facilitates sequestration of calcium during diastole, favoring relaxation and making more calcium available for the next contraction, further improving cardiac ventricular function. Phase 2a and Phase 2b studies in acute heart failure have demonstrated significant improvements in cardiac function as well as increasing blood pressure and preserving or increasing renal function.

The U.S. Patent, titled: “Istaroxime-Containing Intravenous Formulation for the Treatment of Acute Heart Failure (AHF)”, is a continuing patent application of the expedited U.S. Track One filing by Windtree, which resulted in U.S. Patent No. 11,197,869 B2 that issued December 14, 2021. The claims cover longer infusion durations of istaroxime for improved outcomes in treatment of acute heart failure. In particular, the claims are directed to an improvement in diastolic heart function following administration of istaroxime by intravenous infusion for 6 hours or more, which Windtree attributes to the SERCA2a mechanism of action of istaroxime and its metabolites.

“We are pleased with this notice of allowance for a new patent that will continue to strengthen the istaroxime patent estate,” said Craig Fraser, President and Chief Executive Officer of Windtree. “Cardiogenic shock and acute heart failure are areas that need innovation for patients and through three Phase 2 studies, istaroxime has consistently demonstrated a unique and we believe, a highly attractive profile. We look forward to continued progress in development as well as building upon our patent estate for both programs.”

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