Shares of Windtree Therapeutics Inc. (NASDAQ: WINT) gained 50.80% in pre-market trading after the company announced encouraging results from a clinical trial. The shares closed Wednesday’s session at $0.32, up 2.46%.
How did WINT’s results turn out?
The European Journal of Heart Failure published the results of Windtree Therapeutics (WINT) Phase 2 istaroxime study in early cardiogenic shock today. An individual with cardiogenic shock will have low blood pressure and hypoperfusion of the end organs, due to a failing heart. It requires immediate treatment and is associated with high mortality and morbidity rates. In a study called SEISMiC, Windtree Therapeutics evaluated istaroxime in patients with early cardiogenic shock.
What has WINT found?
Despite the fact that WINT’s istaroxime has shown an acceptable tolerability profile in Windtree Therapeutics studies to date, it can improve blood pressure and cardiac function in failing hearts rapidly and significantly with an acceptable tolerability profile in the European Journal of Heart Failure.
It supports the rationale for istaroxime as a potential treatment for cardiogenic shock, and its positive results are consistent with previous Phase 2 studies in acute heart failure. The next step for WINT in its istaroxime development program is to optimize the dosing regimen for a limited number of early cardiogenic shock patients and meet with the FDA about the possibility of a Phase 3 clinical trial. Compared to the control group, Windtree Therapeutics’ SEISMiC study significantly improved systolic blood pressure at 6 hours, one of the most important clinical objectives in the treatment of cardiogenic shock.
At 24 hours, the blood pressure profile remained significantly improved. With istaroxime, patients experienced a substantial increase in stroke volume (the amount of blood pumped by the heart at each contraction), leading to an increase in cardiac output without an increase in heart rate. In addition, several secondary cardiac function endpoints were achieved in this study, including the left atrial area and left ventricular end-systolic volume. Treatment also reduced left ventricular diastolic volume. However, renal function did not worsen.
What progress can WINT made ahead?
It is expected that the Windtree Therapeutics (WINT) study will lead to significant advances in treatment for patients with heart failure and cardiogenic shock in the future. As a result, WINT aligned its resources and activities to prioritize a cardiogenic shock program, which can serve as a relatively fast and less expensive development and regulatory pathway in a market with high unmet needs.