The disclosure of progress in a clinical study has resulted in a large boost in the stock value of Windtree Therapeutics, Inc. (NASDAQ: WINT). As of the latest pre-hours check, Windtree stock has risen 55.12% to $4.95.
Windtree Completed Enrollment In A Significant Study
The SEISMiC Extension Phase 2b trial, conducted by Windtree Therapeutics to examine the effectiveness of istaroxime in treating early cardiogenic shock occurring from heart failure, has successfully concluded patient enrollment. The purpose of this study is to evaluate istaroxime’s ability to improve heart function and maintain hypotension in early cardiogenic shock cases.
WINT is Building on Previous Positive Results
The current SEISMiC Extension Study seeks to extend the promising outcomes observed in the earlier SEISMiC Phase 2 study. This prior research suggested that istaroxime could positively impact renal function and did not contribute to an increase in cardiac arrhythmias.
The Extension Study employs a prolonged dosing regimen with gradual tapering to evaluate the potential benefits further. Istaroxime, a pioneering first-in-class therapy, has previously shown its ability to improve systolic contraction, diastolic relaxation, and blood pressure, while also supporting or enhancing renal function in patients with acute heart failure through three successful Phase 2 trials.
International Scope and Future Prospects
Conducted across the U.S., Europe, and Latin America, the SEISMiC Extension Study aims to build upon the favorable results of the initial SEISMiC Phase 2 study. The study focuses on optimizing dosages and further exploring istaroxime’s novel SERCA2a mechanism, which could offer significant advantages for patients experiencing cardiogenic shock.
Additionally, detailed data on cardiac function and safety, particularly regarding arrhythmias, are being collected. Windtree Therapeutics believes that istaroxime’s lack of association with increased cardiac arrhythmias could differentiate it from existing therapies.
Next Steps and Anticipated Results
Completing enrollment in the SEISMiC Extension Study represents a critical milestone for advancing the istaroxime program towards Phase 3 trials. Concurrently, the SEISMiC C study continues to explore more severe cardiogenic shock cases. Windtree anticipates releasing topline results from the SEISMiC Extension Study by the end of the month and plans to present these findings at an upcoming major medical conference.
