WARRINGTON, PA / ACCESSWIRE / July 25, 2023 / Windtree Therapeutics Inc. (NASDAQ:WINT) is looking to revolutionize acute care treatment for patients with serious conditions like acute heart failure (AHF) and cardiogenic shock (CS). The congestive heart failure market is worth $6.7 billion, and millions of Americans suffer from heart failure every year.
The company is developing its lead drug candidate, istaroxime, to address this acute care market. Istaroxime is a first-in-class therapy with a dual-action mechanism that improves both the systolic (contracting) and diastolic (relaxing) pumping actions of the heart. The drug can simultaneously improve blood pressure while improving cardiac function.
According to Windtree and the market research, there are currently no adequate treatments either on the market or in development specifically for addressing CS, which is a critical condition where the heart cannot pump enough blood around the body. This results in a combination of dangerously low blood pressure and hypoperfusion to vital organs and a mortality rate of 30-40%. Treatments that are currently used for patients with CS include inotropes and vasopressors, however, the treatments have poor outcomes and can increase the risk of adverse effects, including arrhythmias, decreased blood pressure and renal dysfunction.
How Istaroxime Works May Be Truly Unique
Windtree has run three global phase 2 trials for istaroxime, which is currently being developed for CS and AHF indications. The rationale for istaroxime's CS indication came from the successful phase 2a and 2b trials for AHF, where the drug showed improved cardiac and renal function, along with dose-related significant increases in systolic blood pressure. Istaroxime achieved these results without many of the side effects common to other AHF treatments.
Now Windtree has placed all its resources into development of istaroxime in CS because of its recent positive CS Phase 2 trial and a potential fast, less expensive path to development and regulatory approval. The company believes there may also be other significant CS pharmacoeconomic claims for istaroxime and these would be very valuable for commercialization.
Next Generation Dual-Mechanism SERCA2a Activators Could Be Fast Follow-On To Istaroxime In Heart Failure
Istaroxime uses a dual mechanism of SERCA2a activation and Na+/K+ pump inhibition. The dual mechanism of action used by istaroxime has also led to the development of a next generation family of drugs called dual mechanism SERCA2a Activators capable of treating both acute and chronic heart failure.
Windtree recently received a notice of allowance from the U.S. Patent and Trademark Office for its patent application that covers its dual mechanism SERCA2a Activators. These product candidates are designed to be administered both orally and intravenously and may be used for both inpatient and outpatient treatment of either acute or chronic heart failure. For AHF, the dual mechanism SERCA2a Activators could serve as a fast follow-on to istaroxime for hospital inpatient treatment. Continued development of the oral formulation of the dual mechanism SERCA2a Activators could provide an opportunity for chronic treatment after the patient is discharged from the hospital.
Windtree Upcoming Milestones and News Flow
With the advanced development of istaroxime, as well as the granted composition of matter patent on its next generation dual mechanism SERCA2a Activators, Windtree seems confident it is positioned to take advantage of some opportunity drivers in the market. These include the very high cost of CS treatment, which could be softened by the pharmacoeconomic benefits of istaroxime. Additionally, there are no competitive drugs being developed in CS and no adequate drugs to treat CS on the market today.
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).
"We are pleased to see the continued development progress of istaroxime in cardiogenic shock and in our next generation dual mechanism SERCA2a Activators IP portfolio strategy," said Craig Fraser, CEO and President of Windtree Therapeutics, commenting on the news. "The development strategy with these dual mechanism SERCA2a Activators is for potential ‘fast follow-on' drug candidates that can leverage the experience with istaroxime and provide the potential added feature of oral bioavailability for use as a treatment for chronic heart failure."
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