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ONY296615 is an investigational lung surfactant therapy being developed by ONY Biotech for the treatment of neonatal respiratory diseases, primarily neonatal respiratory distress syndrome (RDS). Currently in Phase 3 clinical development, ONY296615 is a specialized candidate within ONY Biotech's neonatology portfolio, which is centered on surfactant replacement therapies. While the specific molecular identity is not publicly disclosed, the candidate is developed based on the company's expertise with calfactant (Infasurf), a natural bovine-derived lung surfactant. ONY296615 is likely a new formulation or delivery protocol for surfactant administration, potentially optimized for non-invasive delivery methods such as aerosolization or administration via supraglottic airway devices (e.g., AerVia). The therapy functions by replacing deficient endogenous surfactant in premature infants, thereby reducing alveolar surface tension, preventing lung collapse (atelectasis), and improving pulmonary gas exchange.
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