Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today announced that the European Patent Office has granted Patent No. 3805243, providing composition of matter patent coverage for the pure SERCA2a Activator class of drug candidates. The pure SERCA2a Activators are one of two families of preclinical drug candidates that act on SERCA2a in the Company’s pipeline. The pure SERCA2a Activators are devoid of action on the Na+/K+ pump while activating SERCA2a. The new European patent, titled: “ANDROSTANE DERIVATIVES WITH ACTIVITY AS PURE OR PREDOMINANTLY PURE STIMULATORS OF SERCA2A FOR THE TREATMENT OF Heart Failure,” provides patent protection until October 9, 2039 for the family of compounds with the pure SERCA2a mechanism of action. The other family of SERCA2a Activators is the dual mechanism of action (inhibition of the Na+/K+ pump and activation of SERCA2a) which the Company previously announced had received composition of matter patents from the European Patent Office and the U.S. Patent and Trademark Office.
The pure SERCA2a Activators have SERCA2a stimulatory activity, are intended to have oral and intravenous administration and would potentially be developed for use in the chronic out-patient heart failure market as well as the acute setting. In the U.S., approximately 6 million people (nearly 2% of the adult population) have heart failure and approximately half of these patients are expected to die within five years of diagnosis; and in the combined U.S., EU and Japan markets, there are more than 18 million patients suffering from heart failure. Heart failure is the leading cause of hospitalization in patients aged 65 years and older.
“SERCA2a activity is decreased in heart failure. Windtree believes activation of SERCA2a represents a potentially important advancement in heart failure treatment for patients,” said Craig Fraser, CEO of Windtree Therapeutics. “Heart failure with preserved ejection fraction (HFpEF) is a condition in which the heart’s main pumping chamber (left ventricle) becomes stiff and unable to fill properly. SERCA2a activation has the potential to be beneficial in this type of heart failure that accounts for nearly one-half of the chronic heart failure patients. Given the potential for oral (tablet) use, it could be utilized in both the chronic out-patient and hospital markets.”
About Pure SERCA2a Activators
These compounds activate SERCA2a without activity on the Na+/K+ pump. Windtree Therapeutic’s research program is evaluating these preclinical product candidates in heart failure.
About Dual Mechanism SERCA2a Activators
Dual Mechanism SERCA2a Activators activate SERCA2a and inhibit the Na+/K+ pump. Windtree Therapeutic’s research program is evaluating these preclinical product candidates in heart failure.
About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is advancing multiple late-stage interventions for 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 pre-clinical heart failure platform includes follow-on, potentially oral, SERCA2a activator assets as well. In pulmonary care, Windtree has focused on facilitating the transfer of the KL4 surfactant platform, to its licensee, Lee’s Pharmaceutical (HK) Ltd. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.
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