Windtree Therapeutics has announced that Lee’s Pharmaceutical Holdings will provide funding for a Phase 2b study of Windtree’s Aerosurf inhaled KL4 surfactant for the treatment of respiratory distress syndrome in preterm infants. Windtree will repay 125% of the funding to Lee’s from revenues or other payments resulting from activities related to the KL4 surfactant/Aerosurf patent portfolio. The company has signed a binding term sheet for the financing; a definitive agreement is expected to be signed by the end of September 2020, and “certain existing royalty provisions” in a June 2017 agreement between the companies will be amended.
Windtree initially partnered with Lee’s for development of Aerosurf in Asia in June 2017, and Lee’s acquired a controlling interest in Windtree in August of that year. Windtree recently said that it was evaluating inhaled KL4 surfactant for the treatment of acute respiratory distress syndrome (ARDS) in COVID-19 patients and is working with Lee’s on the possibility of similar studies in China.
In May 2018, Windtree announced that it had received $700,000 in funding for a follow up of Phase 2b study of Aerosurf through a Small Business Innovation Research Grant (SBIR) from the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) that was initially awarded in 2016 for Phase 2 development of Aerosurf. A previous Phase 2b clinical trial of Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants receiving nasal continuous positive airway pressure (nCPAP) failed to meet its primary endpoint.
Windtree Therapeutics CEO Craig Fraser commented, “Our company has a great partnership with Lee’s and this arrangement is designed to fund the Aerosurf bridge study both globally and in China and ensures the strength of expertise in the KL4 franchise can be applied to our clinical pursuits. This non-dilutive financing from Lee’s also enables us to focus our cash on opportunities in our istaroxime cardiovascular clinical programs – namely the cardiogenic shock clinical study as well as study start up activities for the next acute heart failure phase 2b trial.”
Read the Windtree Therapeutics press release.
