By World Medical Network Airway Therapeutics, Inc. (Airway) is a biopharmaceutical company focused on developing a new class of biologics to break the cycle of injury and inflammation in patients with respiratory and inflammatory diseases. The company announced the first patient to receive dosing in a Phase 1b randomized trial of AT-100 (rhSP-D) for the prevention of the risk of bronchopulmonary dysplasia (BPD) in very preterm infants. This clinical trial will confirm the feasibility of intratracheal administration of AT-100 and its beneficial safety and tolerability profile.
Very preterm infants with incompletely developed lungs must be intubated and mechanically ventilated to ensure breathing. While mechanical ventilation and oxygenation can be life-sustaining, it can damage delicate lung tissue, leading to inflammation and infection, which can lead to scarring and increased susceptibility to infection and chronic disease, including BPD, which affects 2.5 million very preterm infants each year.
While mechanical ventilation is necessary to keep most very preterm infants alive, the resulting inflammation, lung injury and lung arrest increase the risk of BPD, for which there are currently no approved therapies," said Marc Salzberg, MD, CEO of Airway Therapeutics. We are excited to begin the evaluation of AT-100 as a preventative treatment option to reduce the incidence, severity and consequences of BPD in very preterm infants, thereby improving patient prognosis and providing hope for patients' families."
Airway AT-100 is a recombinant version of endogenous human SP-D, a protein essential for lung immune defence that reduces inflammation and infection in the body while modulating the immune response. In preclinical studies, AT-100 has been shown to reduce inflammation and infection caused by mechanical ventilation and oxygenation, and ultimately reduce the occurrence of lung injury.
The development of BPD can have lifelong consequences for affected infants and their caregivers, including asthma, recurrent pneumonia, and growth and developmental problems," said Brenda Poindexter, M.S., M.D., Chief of Neonatology, Director of Neonatal Systems Medicine and Professor of Pediatrics at Children's Healthcare of Atlanta and Emory University. Preclinical data suggest that AT-100 is expected to be the world's first commercially available product for the prevention of BPD, improving prognosis and enabling efficacy beyond the current standard of care."
The Phase 1b trial is currently enrolling very preterm infants who require intubation and mechanical ventilation. The randomised dose-escalation study aims to assess the safety and tolerability of AT-100 compared to air sham surgery alone in 36 patients.
AT-100 is also being evaluated for therapeutic use in an ongoing Phase 1b trial (NCT04659122) in patients with severe neocoronary pneumonia requiring intubation and mechanical ventilation.
About AT-100
AT-100 (rhSP-D) is a novel recombinant endogenous human protein, hSP-D, that reduces inflammation and infection in the body while modulating the immune response and breaking the cycle of injury and inflammation. airway is focused on advancing AT-100 for the prevention of BPD in very preterm infants and as a therapeutic agent in patients with severe neoconjunctivitis. the anti-inflammatory and anti-infective properties of AT-100 also make it useful for AT-100's anti-inflammatory and anti-infective properties also make it a potential drug for the treatment of other respiratory diseases such as influenza, respiratory syncytial virus (RSV) and extrapulmonary inflammatory diseases. The US Food and Drug Administration (FDA) and the European Medicines Agency have granted orphan drug status to AT-100.
About Airway Therapeutics
Airway Therapeutics is a biopharmaceutical company focused on developing a new class of biologics, starting with the most vulnerable populations, to break the cycle of injury and inflammation in patients with respiratory and inflammatory diseases. The company is advancing a novel recombinant human protein, hSP-D, an endogenous version of the protein that reduces inflammation and infection in humans while modulating the immune response. AT-100 is the first drug candidate being developed by Airway for the prevention of BPD in very preterm infants and for the treatment of patients on severe mechanical ventilation for neocoronary pneumonia.
