Windtree Therapeutics Announces Positive Istaroxime Phase 2 Study in Early Cardiogenic Shock (SEISMiC) Published in the European Journal of Heart Failure
WARRINGTON, Pa., Sept. 28, 2022 (GLOBE NEWSWIRE) — Windtree Therapeutics, Inc. (NasdaqCM: WINT), a biotechnology company focused on advancing multiple late-stage interventions for acute cardiovascular disorders, today reported that the results of its positive Phase 2 istaroxime study in early cardiogenic shock were published in the European Journal of Heart Failure (https://doi.org/10.1002/ejhf.2629). Cardiogenic shock is caused by a failing heart resulting in diminished cardiac output to the body and is characterized by very low blood pressure and hypoperfusion to end-organs. It requires urgent treatment and has a high morbidity and mortality. Windtree conducted a study called SEISMiC of istaroxime in patients experiencing early cardiogenic shock due to heart failure.
“The results published in the European Journal of Heart Failure demonstrate that istaroxime can rapidly and significantly improve blood pressure and key parameters of cardiac function in a failing heart with an acceptable tolerability profile in our studies to date,” said Dr. Steven Simonson, Chief Medical Officer of Windtree. “The positive results of the SEISMiC study are consistent with previous Phase 2 studies in acute heart failure and help substantiate and advance the rationale for istaroxime as a potential treatment for cardiogenic shock. We look forward to the next steps of the istaroxime development program in which we plan to extend and optimize our dosing regimen with a small number of early cardiogenic shock patients and meet with the FDA to discuss the potential Phase 3 program.”
The SEISMiC study met its primary endpoint of significantly improved systolic blood pressure, a critical clinical objective in treating patients with cardiogenic shock, compared to the control group at 6 hours. The significant improvement in blood pressure profile persisted through 24 hours. Patients treated with istaroxime experienced a substantial increase in stroke volume (the amount of blood pumped from the heart with each contraction) that contributed to an increased cardiac output without increasing heart rate. The study met several other secondary endpoint assessments of cardiac function including left atrial area and left ventricular end systolic volume. Left ventricular end diastolic volume was also decreased with treatment. Importantly, renal function was not worsened.
“This study represents a potentially important innovative advancement in the treatment for heart failure related cardiogenic shock patients in the future,” said Craig Fraser, President and Chief Executive Officer of Windtree. “We believe the cardiogenic shock program has the potential to be a relatively fast and less expensive developmental and regulatory pathway in a critical market with high unmet need and, as such, we aligned our resources and activities to prioritize this program. We look forward to keeping everyone updated on our progress.”
About Cardiogenic Shock
Cardiogenic shock is a serious condition that occurs when the heart is failing significantly and cannot pump enough blood and oxygen to the brain, kidneys, and other vital organs. Mortality rates are significant and, depending on severity, range from 7% to 40% in the U.S. There is a lack of satisfactory pharmacological intervention to reverse the condition as available therapies have unwanted side effects such as risk for arrhythmias, decreasing blood pressure, renal dysfunction and even increases in mortality that limit their usefulness and position them as “rescue medicines” for severe cases. Market research revealed 99% of 100 U.S.-based clinical cardiologists interviewed who treat cardiogenic shock patients responded that new drug innovation to treat SCAI class B cardiogenic shock patients is highly needed. The cardiogenic shock worldwide total market value is estimated to be $1.25 billion, calculated by using cardiogenic shock patient US hospital claims and worldwide prevalence data multiplied by assumed various regional prices of drug treatment.
About Windtree Therapeutics
Windtree Therapeutics, Inc. is advancing multiple late-stage interventions for acute cardiovascular disorders to treat patients in moments of crisis. Using new scientific and clinical approaches, Windtree is developing a multi-asset franchise anchored around compounds with an ability to activate SERCA2a, with lead candidate, istaroxime, being developed as a first-in-class treatment for acute heart failure and for early cardiogenic shock. Windtree’s heart failure platform includes follow-on oral pre-clinical SERCA2a activator assets as well. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.
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