By M. Marin
Windtree Therapeutics, Inc. (NASDAQ:WINT) has recently had positive updates on its assets and clinical programs, as the company advances drug candidate istaroxime and drug/device combination AEROSURF/KL4 surfactant toward FDA approval. The company is a biopharma and medical device company developing therapies for a range of acute cardiovascular and pulmonary conditions that necessitate critical care, including acute heart failure (AHF), cardiogenic shock (CS) due to heart failure, respiratory distress syndrome (RDS) in premature babies and other lung injuries, including lung injury caused by COVID-19.
– New patent for AEROSURF programs
– New head of cardiac clinical development
– First patient dosed in COVID-19 study
Expanding & extending IP Protection
WINT has been issued a new patent that covers aspects of an updated aerosol delivery system (ADS) for AEROSURF®, one of WINT’s two lead assets. AEROSURF is a drug/device combination for the treatment of respiratory conditions. The new patent expands the company’s IP portfolio related to aerosolized delivery of pulmonary surfactants, alone or combined with other agents, and extends the protection until 2039.
Windtree updated the ADS platform design following the phase 2 clinical program evaluating AEROSURF in treating preterm infants with respiratory distress syndrome (RDS). The company improved the ergonomics, interface, controls, and dose monitoring in the updated platform in a modular design, changes that are expected to mitigate the risks of device-related treatment interruptions.
New Experienced Executive To Oversee Cardiovascular Clinical Development Programs…
WINT’s other lead asset is Istaroxime, which addresses cardiac conditions and has a dual mechanism of action that is a key differentiator versus other treatments. WINT recently appointed Dr. Joseph Soffer to be its Executive Director of Clinical Development and head its cardiovascular clinical development program. He has more than 30 years of experience in industry, clinical practice, and academia, including extensive experience with pharmaceutical industry drug development. The first patient in WINT’s Phase 2 istaroxime study in patients with early cardiac shock was dosed in October 2020.
… And Pulmonary Studies Also Moving Forward
Last month, Windtree announced that it had dosed the first patient in its Phase 2 clinical trial studying its synthetic KL4 surfactant in acute lung injury in adults with COVID-19 associated lung injury and acute respiratory distress syndrome (ARDS). If the initial results from the Phase 2 study demonstrate adequate safety/tolerability and efficacy on physiological variables, WINT intends to advance to further clinical trials.
Multiple Advanced Clinical Programs
WINT has four advanced clinical programs that it is developing and believes that each of its clinical programs addresses a large unmet need and provides another avenue of potential regulatory approval from the FDA.
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