WARRINGTON, PA — Windtree Therapeutics, Inc. (NasdaqCM: WINT) announced that its abstract entitled “Safety and Efficacy of Istaroxime 1.0 and 1.5 µg/kg/min for Patients with Pre Cardiogenic Shock” has been accepted for presentation at the Technology and Heart Failure Therapeutics Conference (THT) being held on March 20-22, 2023 in Boston, MA.
The data are from the Company’s SEISMiC Phase 2 study, an international, randomized, double blind, placebo-controlled study that enrolled 60 patients with Society for Cardiovascular Angiography & Interventions (SCAI) Stage B early cardiogenic shock due to severe heart failure with SBP between 75-90 mmHg. Two target doses of istaroxime were studied compared to placebo. The primary endpoint was the difference in SBP area under the curve over six hours after initiating the infusion. As previously reported, the study met its primary endpoint in SBP profile over six hours, with the pooled istaroxime treated group performing significantly better compared to the control group (p =0.017). The improvement persisted through the 24-hour SBP profile measurement, which was also statistically significant (p=0.025). More detailed analysis of the trial data by dose will be presented at this meeting.
“Windtree is pleased to share this analysis of the istaroxime SEISMiC data at the THT Conference,” said Dr. Steve Simonson, Chief Medical Officer and SVP of Windtree Therapeutics. “The positive Phase 2 SEISMiC study demonstrated the potential for istaroxime to simultaneously increase cardiac output and blood pressure. Additionally, renal function was preserved and there was no increase in cardiac arrhythmias by Holter monitoring. A drug with this unique profile would be a valuable therapeutic tool for the treatment of cardiogenic shock due to heart failure. The analysis by dose is extremely important data to advance istaroxime to the next clinical trials. We look forward to the presentation/discussion at the conference.”
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