WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) announced its strategy to secure 7.5 years of U.S. exclusivity for istaroxime, its investigational treatment for cardiogenic shock, if approved by the FDA. The company disclosed advice from intellectual property and FDA experts highlighting the potential for istaroxime to gain New Chemical Entity (NCE) designation, which could provide 5 years of data exclusivity and extend market protection to 7.5 years in the event of a generic challenge.
Additionally, istaroxime benefits from robust intellectual property protections, including a U.S. Patent and Trademark Office-issued method of use patent valid until 2039 and a pending patent extending until 2043.
“We believe that the NCE exclusivity strategy is an attractive approach if istaroxime receives FDA approval in cardiogenic shock,” said Jed Latkin, Chief Executive Officer of Windtree. “It would be combined with our method of use patents for istaroxime in the U.S. We continue our focused development and IP strategic planning for istaroxime, with the next milestone being an interim analysis of our Phase 2 cardiogenic shock SCAI Stage C study in Q3, 2025.”
The ongoing SCAI Stage C clinical trial, named SEISMiC C, is assessing the efficacy of istaroxime in improving cardiac function among cardiogenic shock patients. This placebo-controlled, double-blinded study involves sites across the U.S., Europe, and Latin America. The trial evaluates the systolic blood pressure profile over six hours of treatment alongside secondary outcomes such as cardiac function, time to treatment failure, and hospital stay duration.
Istaroxime’s unique dual mechanism works by improving both systolic and diastolic cardiac function. Clinical data from earlier Phase 2 trials have shown significant cardiac function improvements without heightening heart rate or causing rhythm disturbances, solidifying its potential as a first-in-class therapy for critical cardiac conditions.
Through strategic planning and scientific development, Windtree Therapeutics aims to position istaroxime as a game-changing treatment for cardiogenic shock, addressing an important unmet medical need while securing intellectual property protections for long-term market success.
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