Windtree Therapeutics Strengthens Patent Portfolio for Heart Failure Drug Istaroxime with International Approvals
Key Insights
Windtree Therapeutics received patent approvals for istaroxime in Canada and Mexico, plus a pure SERCA2a (search) activator patent in Israel, expanding its cardiovascular intellectual property portfolio.
The company now holds 59 issued or allowed patents and 17 pending patents for istaroxime and SERCA2a (search) activators targeting heart failure treatment.
Istaroxime demonstrates unique advantages over current treatments by improving cardiac function without increasing arrhythmias or compromising renal function in Phase 2 studies.
Windtree Therapeutics has expanded its international patent protection for istaroxime, a first-in-class heart failure therapy, with new approvals in Canada and Mexico, while also securing patent rights for next-generation SERCA2a (search) activators in Israel. The company announced that its cardiovascular patent estate now encompasses 59 issued or allowed patents with 17 pending applications.
The newly approved patents include acute heart failure applications in Canada (Patent Application No. 3,130,261) and Mexico (Patent Application No. MX/a/2021/010483), along with a pure SERCA2a (search) activator patent for heart failure granted in Israel (Patent Application No. 291412). This intellectual property portfolio covers istaroxime, dual mechanism SERCA2a activators, and pure SERCA2a activators for treating heart failure, preventing arrhythmias, and managing cardiogenic shock.
Addressing Critical Medical Need
Heart failure represents a significant global health burden, affecting 60 million people worldwide. Approximately 20 million patients are hospitalized annually for acute heart failure, including 1.5 million in the United States. The condition carries particularly high mortality rates among patients with systolic blood pressure below 120 mmHg, where in-hospital and 6-month mortality can reach double-digit percentages.
Current treatment options for acute heart failure remain limited and often carry significant side effects, including arrhythmias and renal function complications. Hospital readmission rates, worsening heart failure, and mortality continue to present challenges requiring innovative therapeutic approaches.
Unique Dual-Mechanism Approach
Istaroxime operates through a distinctive dual-mechanism design that simultaneously improves both systolic and diastolic cardiac function. The drug functions as a positive inotropic agent, increasing myocardial contractility through Na+/K+-ATPase (search) inhibition while facilitating myocardial relaxation through SERCA2a (search) calcium pump activation on the sarcoplasmic reticulum, enhancing calcium reuptake from the cytoplasm.
Clinical data from multiple Phase 2 studies in patients with early cardiogenic shock or acute decompensated heart failure demonstrate that intravenous istaroxime infusion can significantly improve cardiac function and blood pressure without increasing heart rate or the incidence of clinically significant cardiac rhythm disturbances.
Development Strategy and Future Plans
"We are very pleased to be strengthening our cardiovascular patent estate," said Jed Latkin, Chief Executive Officer of Windtree. "We believe that istaroxime has a unique profile to effectively treat acute heart failure patients with low blood pressure, who are most in need. Further, istaroxime has demonstrated favorable results in renal function and no increase in arrythmias that is lacking with currently available drugs."
The company is actively pursuing partnership opportunities for development and considers the clinical studies conducted to date encouraging for advancing to a Phase 3 program. Windtree's research and development program also includes evaluation of preclinical pure SERCA2a (search) activator candidates, encompassing both oral and intravenous formulations for heart failure treatment.
Expanding Pipeline
Beyond istaroxime, Windtree is developing pure SERCA2a (search) activators as next-generation compounds that specifically target the SERCA2a pathway. These preclinical candidates represent potential oral and intravenous treatment options for heart failure patients, expanding the company's cardiovascular therapeutic portfolio.