WARRINGTON, PA / ACCESSWIRE / July 14, 2023 / Windtree Therapeutics, Inc. (NASDAQ:WINT), a biotechnology company treating late-stage acute cardiovascular disorders, is advancing its first-in-class drug for serious heart conditions. The company believes that this treatment - named Istaroxime - can fill a niche in the market for serious heart conditions like cardiogenic shock and acute heart failure.

The first-in-class dual-action drug treats patients with acute decompensated heart failure (ADHF), a condition where the patient gradually or suddenly experiences severe signs of heart failure. Heart failure refers to the state in which the heart's ability to pump blood around the body is affected, causing symptoms ranging from tiredness, trouble breathing and swelling ankles to organ failure and death.

Istaroxime's novel dual mechanism of action (MoA) simultaneously improves systolic heart contractions as well as activates SERCA2a to cause better relaxation in between heartbeats. These two mechanisms significantly increase cardiac function and improve patient blood pressure. Unlike other treatments for heart failure, Istaroxime is also able to accomplish this with a differentiated renal and safety profile.

Heart Failure Market

Windtree is positioning itself in a growing heart failure market. The congestive heart failure market was worth $6.7 billion in 2022 and is expected to reach $13.5 billion by 2031 at a compound annual growth rate (CAGR) of 7.6% during the forecast period.

In America, over 6 million adults suffer from heart failure, and the rise in the geriatric population, along with unhealthy lifestyles, are major drivers in the growth of the market. North America holds the largest revenue share in the market, though the Asia Pacific region is the largest growing segment of the market.

Across all stages of congestive heart failure, the 5-year survival rate is 50%. However, a much more severe form of congestive heart failure is cardiogenic shock (CS). CS involves very low blood pressure and hypoperfusion and is always treated as an emergency. Its in-hospital mortality rate is from 35-50%.

Treatments For Cardiogenic Shock

Windtree reports that right now there aren't any adequate drugs on the market or any drugs in development other than Istaroxime that can address CS by treating blood pressure and cardiac function together without significant side effects. Current pharmacological treatments like inotropes are used to increase cardiac output, or furosemide to help the patient urinate.

However, these older treatments have not proved to be effective and safe, and the use of inotropes has even shown itself to be counterproductive. They can increase the likelihood of irregular heart events, known as arrhythmias, as well as hypotension and increased risk of death.

This suggests that there is a position for Windtree to fill with its drug Istaroxime. In a survey of U.S. cardiologists by Sermo, an overwhelming majority of cardiologists said there was a large, unmet need for innovative pharmacologic treatments for early CS. 84% of respondents also said they would be either likely or extremely likely to use Istaroxime for patients with early CS.

Istaroxime has completed three positive phase 2 trials for both CS and acute heart failure, and Windtree is looking to move to the next stage in the development pipeline. For its acute heart failure indication, Istaroxime already has a Food and Drug Administration (FDA) fast-track regulatory designation.

Windtree milestones and news flow over the next several quarters: cardiogenic shock SEISMiC Extension Study, SCAI Stage C Study and SERCA2a Activator advancement (IP, publications).

The rapid development and commercialization of this drug could also impact Medicare spending for patients. 5% of the sickest patients account for about half of all healthcare spending, with a long length of stay in hospitals further driving high costs. If pharmacological treatments for heart failure are unsuccessful, patients may undergo medical intervention, and Windtree cites a study indicating that heart failure is the most expensive Medicare diagnosis.

Companies developing treatments for cardiovascular conditions include Merck & Co., AstraZeneca, Novartis and Bristol Myers Squibb.

Click here to read more about Windtree Therapeutics.

Featured photo by Wavebreak Media on Shutterstock.

Contact:

Matt Epstein
mepstein@kendallir.com

SOURCE: Windtree