Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing late-stage interventions for cardiovascular disorders, today reported that the United States Patent and Trademark Office (USPTO) has issued US Patent No. 11,730,746 covering the Company’s dual mechanism SERCA2a Activators. The new composition of matter patent, titled: “17BETA-HETEROCYCLYL-DIGITALIS LIKE COMPOUNDS FOR THE TREATMENT OF HEART FAILURE,” provides patent protection through late 2039.
The newly issued patent follows the Company’s announcement in April 2023 that the European Patent Office granted Patent No. 3599243, which also provides patent coverage for the dual mechanism SERCA2a Activator class of drug candidates. Windtree has preclinical drug candidates with dual mechanisms of action (inhibition of the Na+/K+ pump and activation of SERCA2a) as well as pure SERCA2a activators (devoid of action on the Na+/K+ pump).
SERCA2a has been known to play a key role in heart failure and has thus been a much sought after but elusive target for several potential drug therapies. Istaroxime and these follow-on SERCA2a Activators look to deliver on the potential of SERCA2a activation in heart failure. The dual mechanism compounds activate SERCA2a and inhibit the Na+/K+ pump in a manner similar to istaroxime, which is administered intravenously (IV) and is the Company’s lead program for cardiogenic shock and acute decompensated heart failure. These new dual mechanism SERCA2a Activator product candidates are intended to be both oral and IV therapies, which could result in a hospital inpatient therapy for acute decompensated heart failure as well as an outpatient oral therapy for hospital discharge and chronic heart failure treatment.
“We are making steady progress with our IP portfolio strategy for the dual mechanism SERCA2a Activator family of drug candidates,” said Craig Fraser, Chief Executive Officer of Windtree Therapeutics. “We plan to position these new compounds as a ‘fast follow-on’ to istaroxime while offering the potential of oral bioavailability for use as a treatment for chronic heart failure. Much may be accomplished for heart failure patient treatment with this innovation.”
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, including oral and intravenous SERCA2a Activator heart failure compounds.
About Istaroxime
Istaroxime is a first-in-class dual mechanism therapy designed to improve both systolic and diastolic cardiac function. Istaroxime is a positive inotropic agent that increases myocardial contractility through inhibition of Na+/K+- ATPase with a complimentary mechanism that facilitates myocardial relaxation through activation of the SERCA2a calcium pump on the sarcoplasmic reticulum enhancing calcium reuptake from the cytoplasm. Data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that istaroxime infused intravenously significantly improves cardiac function and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances.
About Windtree Therapeutics, Inc.
Windtree Therapeutics, Inc. is advancing 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 cardiogenic shock and acute decompensated heart failure. Windtree’s heart failure platform includes follow-on pre-clinical 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. and Zhaoke Pharmaceutical (Hefei) Co. Ltd. Included in Windtree’s portfolio is rostafuroxin, a novel precision drug product targeting hypertensive patients with certain genetic profiles.
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