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Heart Failure

Windtree’s Istaroxime Scores in Cardiogenic Shock Trial

Windtree Therapeutics’ istaroxime appears to have scored in its latest Phase 2b trial, showing that the steroidal drug significantly improves systolic blood pressure in cardiogenic shock patients.

• Istaroxime is a novel dual-mechanism therapy designed to improve both systolic and diastolic cardiac function by increasing myocardial contractility and facilitating myocardial relaxation.
• That could have a major impact on cardiogenic shock outcomes, which rely heavily on blood pressure, and are associated with long/costly hospital stays and high mortality risks.

The Phase 2b SEISMiC extension trial evaluated istaroxime infusions for up to 60 hours in patients with early-stage cardiogenic shock, measuring its impact during the first 96 hours and through a 30-day follow up, finding that istaroxime…

• Significantly improved systolic blood pressure over six hours (the primary endpoint), while notably outperforming the placebo group.
• Showed significant benefits “in many secondary endpoints.” 
• Had a favorable safety profile that was generally consistent with its previous trials.

These results reinforce findings from the previous SEISMiC study, which only administered istaroxime for up to 24 hours, and also found that it significantly improved SBP. 

• The new trial might also reveal more details on istaroxime’s impact on heart function, and its potential to avoid the arrhythmia downsides that are commonly associated with cardiogenic shock therapies.

Although the extension study’s complete results don’t come out until the HFSA Meeting next week, Windtree celebrated this achievement, noting the importance of early stage cardiogenic shock treatments on overall outcomes.

• However, these results apparently weren’t enough to persuade Wall Street, as Windtree’s stock price quickly fell 10% yesterday to $2.90, adding to a 72% slide over the last month.
  

Trial-based stock price swings don’t always predict a drug’s potential impact, but istaroxime’s research momentum could have a major impact on Windtree’s overall business, noting that the company recently revealed that it’s running out of cash and working on strategic alternatives.

The Takeaway

Windtree and istaroxime both still have a lot to prove, but the drug now has four Phase 2 trials supporting its potential for cardiogenic shock and acute heart failure, and it appears to be on its way to a Phase 3 trial. That could be a big deal in the cardiogenic shock space, which many believe is still in need of more effective treatments.

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1. Novo Nordisk CEO testifies on Capitol Hill over high GLP-1 costs.
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