Istaroxime Update: Start Of Patient Dosing In Early Cardiogenic Shock SEISMiC Extension Study In Preparation For Phase 3 Readiness, Topline Data Expected mid-2024

Windtree Therapeutics, Inc. WINT has recently enrolled the first subject in its phase 2 SEISMiC Extension Study to evaluate istaroxime in the treatment of early cardiogenic shock. The phase 2 trial builds upon the positive data from the SEISMiC study in early cardiogenic shock and will add data to facilitate the company’s end-of-phase 2 meeting with the FDA and is expected to lay the groundwork for choosing an optimal dose for a phase 3 trial, subject to FDA approval. 

Cardiogenic Shock Requires Urgent Medical Treatment and Has Significant Unmet Need for Drug Treatment

Cardiogenic shock is characterized by low blood pressure and inadequate blood flow to vital organs and is accompanied by congestion and high filling pressures of the heart. 

Mortality of cardiogenic shock is estimated to be up to 40% in patients and survivors may experience substantial morbidity. 

There is a significant unmet need with current drugs available and a reported desire for drug innovation. Market research was conducted with 100 U.S.-based clinical cardiologists who treat cardiogenic shock as part of their responsibility.  99 out of 100 of cardiologists indicated that drug innovation was highly needed for early cardiogenic shock. Additionally, when shown a blinded profile of istaroxime, 84% of the cardiologists said they would be “likely” or “extremely likely” to use istaroxime to treat their patients. Last, the majority of the 100 cardiologists said they would utilize istaroxime before other available drug therapies.

Istaroxime Has Already Shown Positive Results In An Early Cardiogenic Shock Trial

Istaroxime would be a first-in-class dual-action treatment that can increase blood pressure and improve heart function. 

As for its ability to treat cardiogenic shock, in a recent phase 2 trial conducted by Windtree in early cardiogenic shock, the systolic blood pressure area under the curve was statistically significantly improved over the control group during the six-hour primary endpoint of the study. Systolic blood pressure was measured additionally for 24 hours and maintained statistical significance over the control group during that period of time. The study also found that istaroxime patients showed improvements in overall cardiac function. Istaroxime also had a favorable profile related to arrhythmias and kidney function (two potential points of differentiation for istaroxime versus currently used medicines). 

The SEISMiC Extension Study Could Pave The Way For Phase 3 

The SEISMiC Extension Study is a dose optimization study meant to find the optimal dosage of istaroxime to use if and when it moves into a phase 3 program, which remains subject to the FDA’s approval. This is an important step to phase 3 readiness and will provide data to Windtree for its end-of-phase 2 meeting with the FDA. 

The new phase 2 Extension is expected to enroll up to 30 hospitalized patients with early cardiogenic shock (SCAI Stage B) due to acute heart failure and will evaluate two dose regimens of istaroxime compared to placebo. Subjects on istaroxime will receive infusions for up to 60 hours with one istaroxime group receiving a tapered decreasing dose over time and the second istaroxime group receiving a consistent lower dose.  In the previous SEISMiC study in early cardiogenic shock, patients were infused drug or placebo for 24 hours.  The company believes extending the dosing duration of istaroxime has the potential to provide additional benefit and, along with dose titration, is an important factor in determining the optimal dosing regimen to study in a potential Phase 3 trial.  The Extension Study will also gather data to characterize the potential benefits of SERCA2a activation in these patients, advancing the Company’s clinical and regulatory position for potential Phase 3 readiness. 

Topline results of the SEISMiC Extension Study are expected in mid-2024. The company is also progressing the start-up of a parallel study in the more severe SCAI Stage C patients targeting data in a similar timeframe.    

Featured photo by Ali Hajiluyi on Unsplash.

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