Mr. Zen
2 months ago
Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced the issuance of an istaroxime patent for Japan. The patent is entitled, “Istaroxime-containing intravenous formulation for the treatment of heart failure (AHF).” The claims are directed to intravenous administration of istaroxime using increased infusion times alone or in combination with other agents useful to treat AHF, thereby improving treatment of heart failure and diastolic relaxation when compared to conventional protocols. The application has been accorded Patent No. 7560134 with a registration date of September 24, 2024 and will expire in 2039.
Mr. Zen
3 months ago
Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced it has successfully completed enrollment in its SEISMiC Extension Phase 2b study of istaroxime in early cardiogenic shock caused by heart failure. The study is evaluating the ability of istaroxime to improve heart function and low blood pressure in the setting of early cardiogenic shock due to heart failure. The Company is looking to extend the positive results on these parameters as observed in the Company’s first SEISMiC Phase 2 clinical study that was previously reported. In addition, the Company hopes that the study results will substantiate the encouraging observations from the Company’s Phase 2 clinical study, indicating istaroxime has a favorable renal profile and does not increase cardiac arrhythmias. The SEISMiC Extension Study is utilizing longer dosing duration and tapering the dosing to assess the potential benefits.
Istaroxime is a novel first-in-class therapy that has demonstrated the ability to improve systolic contraction and diastolic relaxation of the heart while also increasing blood pressure and maintaining or improving renal function in patients with compromised cardiac function in three positive Phase 2 trials enrolling patients with acute heart failure (AHF). Cardiogenic shock is a serious condition that can occur when AHF patients continue to deteriorate and the heart cannot pump enough blood and oxygen to the brain, kidneys, and other vital organs. Mortality rates are significant and, depending on severity, range from 7% to 40% in the U.S. There is a lack of satisfactory pharmacological intervention to reverse the condition as available therapies have unwanted side effects such as risk for arrhythmias, decreased blood pressure, and renal dysfunction that limit their usefulness and position them as “rescue medicines” for severe cases. The cardiogenic shock worldwide total market value is estimated to be $1.25 billion per year.