Discovery Laboratories has announced that it will switch its focus from Surfaxin lucinactant intratracheal suspension product to development of its Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome in premature infants. The company said that if it is unable to find a partner for Surfaxin, it will “cease the commercialization” of the product, which was approved in 2012. Aerosurf is currently in Phase 2 development.
Discovery Labs President and CEO John G. Cooper commented, “Although we continue to believe that Surfaxin has the potential to become the market-leading surfactant, we believe our existing capital is best used for the development of Aerosurf, which has the potential to revolutionize the management of RDS and generate the greatest value for our stakeholders. If successful with Aerosurf, we believe that we may be able to develop a pipeline of other aerosolized KL4 surfactant products, potentially to address other respiratory diseases where there are currently significant unmet medical needs.”
According to the company, it expects enrollment in an ongoing Phase 2a trial of Aerosurf to be complete by early in the second quarter of 2015, and preparation for a Phase 2b study is underway. Discovery Labs said that it expects completion of the Phase 2b study in the second quarter of 2016.
Some of the funding for Aerosurf development has come from the the National Heart, Lung, and Blood Institute (NHLBI) of the NIH, including a $1.9 million Fast Track SBIR Grant for the Phase 2a trial and a grant for up to $3 million for development of aerosolized KL4 surfactant for the treatment of radiation-induced lung injuries.
Read the Discovery Labs press release.
