ONY Biotech, a small privately-held neonatology pharmaceutical company based in Buffalo, recently announced the results of a clinical trial on its aerosolized surfactant for newborns with respiratory distress syndrome, a disorder caused by lack of surfactant that can result in collapsed lungs.
ONY Biotech’s aerosolized surfactant turns liquid surfactant into a fine mist, which allows a baby to breathe it in instead of having to be intubated — an invasive process that’s associated with various complications in premature infants. Administered via a modified pacifier, this new method is non invasive, and study results show it has the potential to reduce the need for intubation by 50%.
“This is the most significant milestone in surfactant therapy since 1998, when we were first granted FDA approval for Infasurf (calfactant) — the very surfactant we are now aerosolizing,” said Randy Burkard, president and CEO of the company. “At the end of the day, and frankly at the beginning of every day, this isn’t and never was about us. It’s about premature babies and providing important treatments in their most critical hours”.
The study’s groundwork was laid by ONY Biotech’s founder, chairman, and chief scientific officer, physician Edmund Egan, and spearheaded by James Cummings, ONY’s Chief Medical Officer. Conducted in 22 neonatal intensive care units (NICUs) across the country, its findings have been published in Pediatrics, the official journal of the American Academy of Pediatrics.
With results in print, the aerosolized surfactant will now undergo review by the FDA.