Windtree Therapeutics has received the remaining $700,000 from 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. The company previously received a total of $1.9 million from that award, an initial $1 million in 2016 followed by $900,000 in 2017.
The money will go toward completion of a one-year patient follow-up to a Phase 2b trial of the aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants 26 to 32 weeks gestational age receiving nasal continuous positive airway pressure (nCPAP).
In June 2017, Windtree announced that the Phase 2b trial of Aerosurf failed to meet its primary endpoint. The company blamed interruptions in the delivery of Aerosurf to patients and said that data for infants who received uninterrupted doses demonstrated a meaningful treatment effect.
Windtree President and CEO Craig Fraser said, “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 its support of this program is the result of encouraging results throughout the Aerosurf phase 2 program. Our key objectives for 2018 include completing the one-year patient follow-up for the phase 2b clinical trial, initiating an Aerosurf bridge study to transition to our next generation aerosol delivery system (NextGen ADS) in the clinic, and advancing the Aerosurf program to phase 3. This award from the NIH contributes towards achieving these objectives.”
Read the Windtree Therapeutics press release.
