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WARRINGTON, Pa. - Windtree Therapeutics, Inc. (NASDAQ:WINT), whose stock has surged nearly 49% in the past week according to InvestingPro data, announced Wednesday that the United States Patent and Trademark Office has issued a patent for its istaroxime intravenous formulation for the treatment of acute heart failure. The micro-cap company, currently valued at $2.01 million, continues to advance its pharmaceutical pipeline despite challenging financial metrics.
The patent, application number 18/150,870, would provide protection until 2039 if the drug receives regulatory approval in the United States.
Istaroxime has completed two Phase 2 studies in acute heart failure and two early studies in cardiogenic shock caused by acute heart failure, with the company reporting positive results from these trials.
"We are pleased to strengthen our intellectual property for istaroxime with this patent for the United States," said Jed Latkin, CEO of Windtree, according to the press release.
Acute heart failure affects approximately 1.3 million hospitalized patients annually in the U.S. and is the leading cause of hospitalization for patients over 65 years old.
Istaroxime is described as a first-in-class dual-mechanism therapy designed to improve both systolic and diastolic cardiac function. The drug works by increasing myocardial contractility through inhibition of Na+/K+-ATPase while also facilitating myocardial relaxation through activation of the SERCA2a calcium pump.
Clinical data indicates that when administered intravenously, istaroxime can improve cardiac function and blood pressure without increasing heart rate or causing significant cardiac rhythm disturbances.
The company states that istaroxime is approaching Phase 3 readiness in both cardiogenic shock and acute heart failure indications.
In other recent news, Windtree Therapeutics announced it reached the planned enrollment of 20 patients for the interim analysis in its Phase 2 SEISMiC C study of istaroxime in SCAI Stage C cardiogenic shock patients. The study aims to evaluate the safety and early efficacy of istaroxime, a dual-mechanism therapy designed to improve cardiac function. Additionally, Windtree’s Phase 2 study of istaroxime for early cardiogenic shock was published, showing positive results in improving blood pressure and cardiac output without increasing heart rate. In a strategic move, Windtree has entered into a binding letter of intent to acquire Titan Environmental Solutions for $35 million in preferred stock, along with purchasing notes totaling $1.75 million. The company also received a non-binding offer to sell its preclinical oncology platform for $7 million upfront, with potential milestone payments. Furthermore, Windtree plans to accept cryptocurrency payments, aligning with digital commerce trends. These developments reflect Windtree’s efforts to diversify its operations and explore new revenue opportunities.
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