WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) has initiated patient enrollment for its SEISMiC C trial, targeting SCAI Stage C cardiogenic shock. This trial marks a pivotal step in assessing the efficacy of istaroxime in a severely ill patient group, building on positive outcomes from previous trials in less severe stages of cardiogenic shock.
SCAI Stage C cardiogenic shock is characterized by significant organ hypoperfusion, necessitating the use of inotropic or vasopressor drugs. However, these medications are often accompanied by adverse side effects. Istaroxime has shown promise in earlier studies by improving systolic blood pressure and cardiac function without increasing the risk of arrhythmias, offering a potentially safer alternative to existing treatments.
The SEISMiC C trial is a global, placebo-controlled, double-blinded study involving sites in the U.S., Europe, and Latin America. Istaroxime will be administered alongside standard care therapies, with its effects evaluated over a six-hour period. The trial’s primary endpoint is to monitor changes in systolic blood pressure, with secondary measures including cardiac function, vasopressor-inotrope scores, and the avoidance of progression to more severe shock stages.
A planned interim analysis will occur after approximately 20 patients have been enrolled, providing valuable data to guide the continuation of the study.
Steve Simonson, CMO and SVP of Windtree Therapeutics, expressed optimism about the trial, stating, “We are pleased to have this study underway and enrolling patients. The study is intended to build on the positive results to date and moves us forward into this important SCAI Stage C patient population for the development program.”
The trial’s findings are expected to play a critical role in shaping the Phase 3 development of istaroxime for cardiogenic shock, with the ultimate goal of providing a more effective treatment option for this challenging condition.
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