WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) has announced the issuance of a new patent for istaroxime in Hong Kong, titled “Istaroxime-containing intravenous formulation for the treatment of heart failure (AHF).” This patent covers formulations and methods of using istaroxime, a groundbreaking investigational therapy designed to treat acute heart failure (AHF). The patent, published on October 9, 2024, will remain valid until 2039, following the earlier grant of a patent for mainland China.
The company’s partner, Lee’s Pharmaceutical (HK) Ltd., plans to initiate a Phase 3 clinical program targeting AHF in the Greater China region, funding all associated trials and development. Windtree will collaborate closely with Lee’s, holding final approval authority on the study protocol. This partnership aligns with Windtree’s strategy to expand the global reach of its cardiogenic shock program while Lee’s progresses the AHF indication.
Istaroxime offers a novel approach by enhancing heart contraction and relaxation, increasing blood pressure, and maintaining kidney function, all with a promising safety profile. It has been positively evaluated in four Phase 2 trials involving patients with AHF and early cardiogenic shock linked to heart failure.
Craig Fraser, Chairman and CEO of Windtree, commented on the development, stating, “Acute heart failure is responsible for millions of hospitalizations annually throughout the world and there is a high need for innovation in drug treatment. Expansion of our patent estate helps support our Greater China regional licensing agreement with Lee’s, through which Windtree may receive up to $138 million in potential milestones and low double-digit royalties. We will continue to support our partner with patent and other development work.”
This patent is a significant step for Windtree, enhancing its intellectual property portfolio and potentially advancing treatment options for heart failure in a region where acute heart failure is a leading cause of hospital admissions.
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