[{"orgOrder":0,"company":"Windtree Therapeutics","sponsor":"Lee's Pharmaceutical","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Windtree Enters into Agreement with Lee's Pharmaceutical for Non-Dilutive Funding of the Continued Development of AEROSURF","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Peptide","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Windtree Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Windtree Announces First Patient Enrolled in AEROSURF\u00ae Bridging Study for the Treatment of Respiratory Distress Syndrome","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Peptide","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Windtree Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Windtree Announces Initial European Trial Sites Activated in AEROSURF\u00ae","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Peptide","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Windtree Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Windtree Gets FDA Acceptance of IND Application for a Phase 2 Clinical Trial of KL4 Surfactant in Acute Lung Injury in Adults with COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Peptide","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Windtree Therapeutics","sponsor":"Lee Pharmaceutical","pharmaFlowCategory":"D","amount":"$78.9 million","upfrontCash":"Undisclosed","newsHeadline":"Windtree Therapeutics Announces KL4 Surfactant and AEROSURF\u00ae Global License Agreement","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Windtree Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Windtree Completes Enrollment in Its Phase 2 Study of Lucinactant (KL4 Surfactant) for COVID-19 Associated Lung Injury and Acute Respiratory Distress Syndrome","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Peptide","productStatus":"Approved","date":"February 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Windtree Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Windtree Announces Results from Its Phase 2 Study of Lucinactant for COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS) and Lung Injury","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Peptide","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Deerfield Management","sponsor":"Windtree Therapeutics","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Windtree Eliminates $15 Million Contingent Liability to Deerfield Management Company","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"","productType":"Peptide","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"}]
Find Clinical Drug Pipeline Developments & Deals for Lucinactant
Deerfield has agreed to terminate its rights for development and commercial milestone payments associated with AEROSURF®, an acute pulmonary drug/device combination intended to treat premature infants with respiratory distress syndrome.
Under terms of the global license agreement, Lee’s and Zhaoke will receive a global license to develop and commercialize Surfaxin®, lyophilized lucinactant and AEROSURF (lucinactant) for any potential indications and applications.
The trial demonstrated that intratracheal administration of reconstituted lyophilized Surfaxin (lucinactant), was generally safe and well tolerated and could be safely administered to critically ill, mechanically ventilated patients with severe COVID-19 associated ARDS.
Phase 2 trial will evaluate safety and tolerability of KL4 Surfactant (lucinactant) synthetic surfactant designed to imitate the essential attributes of the human surfactant protein B for patients with COVID-19 associated lung injury and acute respiratory distress syndrome.
FDA has accepted Windtree's Investigational New Drug (IND) application for a Phase 2 clinical trial studying lyo lucinactant, its KL4 surfactant drug, in COVID-19 associated lung injury and acute respiratory distress syndrome (ARDS) patients.
The AEROSURF Phase 2b bridging study is a multicenter, randomized, controlled study with masked treatment assignment in up to 90 premature infants 26 to 32 weeks gestational age (GA) receiving nasal continuous positive airway pressure (nCPAP) for RDS.
Study is intended to complete the phase 2 clinical program for AEROSURF and transition clinical development to phase 3 by validating the performance of the new aerosol delivery system (ADS).
The financing will fund the AEROSURF phase 2b bridge study which, if successful, is intended to transition the product into a phase 3 ready clinical product development.