Windtree Therapeutics has received $1 million from a Phase 2 Small Business Innovation Research Grant (SBIR) worth up to $2.6 million for a Phase 2b trial of its Aerosurf aerosolized KL4 surfactant in premature infants with respiratory distress syndrome (RDS) who are receiving nasal continuous positive airway pressure (nCPAP).
The company previously received a $1.9 million SBIR grant for a Phase 2a trial for the same indicationand an SBIR grant valued at up to $3 million for development of Aerosurf for the treatment of radiation-induced lung injury.
The Phase 2b trial is expected to enroll approximately 240 premature infants receiving nCPAP at as many as 50 sites. The trial began enrolling infants at 29-32 weeks gestational age in late 2015 and will expand to include infants at 26-28 weeks GA after completion of a Phase 2a trial in that age group that is currently underway.
Windtree President and CEO Craig Fraser commented, “We appreciate the NIH’s continued recognition of the importance of our RDS research and support of our Aerosurf development program. We believe that the NIH’s decision to continue to support this program is the result of encouraging results in the Aerosurf Phase 2a trial in premature infants 29 to 34 week gestational age. Our key focus for 2016 remains the rigorous and timely execution of the Aerosurf phase 2 program while effectively managing existing cash resources and this NIH funding contributes directly towards achieving these objectives.”
Read the Windtree Therapeutics press release.
