Airway Therapeutics Announces First Patient Dosed in Phase 1b Trial of AT-100 in Preterm Infants at Risk for Bronchopulmonary Dysplasia (BPD)

Novel preventative AT-100 offers potential to reduce incidence and severity of serious respiratory disease BPD,improving outcomes in very preterm infants

MARIETTA,Ga.,March 31,2022 -- Airway Therapeutics,Inc. (Airway),a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases,announced dosing of the first patient on March 28,2022 in the Phase 1b randomized trial of AT-100 (rhSP-D) for preventative use in very preterm infants at risk for bronchopulmonary dysplasia (BPD). The clinical trial will confirm the feasibility of intratracheal administrations of AT-100 and its beneficial safety and tolerability profile.

Very preterm infants whose lungs are not fully developed must be intubated and ventilated to enable breathing. Although the mechanical ventilation and oxygen support preserves life,it damages delicate lung tissue,causing inflammation and infection which can result in scarring and susceptibility to infections and chronic disease,including BPD for which 2.5 million very preterm infants are at risk globally each year.

"Though mechanical ventilation is necessary for sustaining life in most very preterm infants,the resulting inflammation,lung damage and arrest of lung development increase risk for BPD,for which there are currently no approved treatments," said Marc Salzberg,M.D.,CEO of Airway Therapeutics. "We are excited to initiate evaluation of AT-100 as a preventative treatment option to reduce the incidence,severity and consequences of BPD in very prematurely born infants to improve patient outcomes and provide hope to patients' families."

Airway's AT-100 is a recombinant version of the endogenous human SP-D,a protein essential to the lung's immune defense,designed to reduce inflammation and infection while modulating immune responses. In preclinical studies,AT-100 has shown to reduce inflammation and infection triggered by mechanical ventilation and oxygen support,and ultimately reduce the onset of lung damage.

"Development of BPD can result in lifelong consequences for affected infants and their caretakers including asthma,recurrent pneumonia as well as growth and developmental problems," said Brenda Poindexter,M.S.,Chief of Neonatology,System Medical Director for Neonatology and Professor of Pediatrics at Children's Healthcare of Atlanta and Emory University. "Preclinical data suggest that AT-100 holds promise to become the first globally available commercial product for prevention of BPD,enhancing outcomes beyond the current standard of care."

The Phase 1b trial is currently enrolling very prematurely born infants requiring intubation and mechanical ventilation. The randomized dose escalation study is designed to evaluate the safety and tolerability of AT-100 in 36 patients as compared to air-sham procedures alone. Airway anticipates data in 1Q2023. The Phase 1b trial will be followed by a randomized Phase 3 trial with preliminary results expected as soon as 2Q2024. For more information about the trial,refer to the clinicaltrials.gov identifier: NCT04662151.

Concurrently,AT-100 is also being evaluated for therapeutic use in severely ill COVID-19 patients requiring intubation and mechanical ventilation in an ongoing Phase 1b trial (NCT04659122).

About AT-100

AT-100 (rhSP-D) is a novel recombinant version of the endogenous human protein hSP-D,a protein that reduces inflammation and infection in the body while modulating the immune response to break the cycle of injury and inflammation. Airway is focused on advancing AT-100 for the prevention of BPD in very preterm born babies and as a therapeutic for seriously ill COVID-19 patients. AT-100's anti-inflammatory and anti-infective properties also make it a potential treatment for other respiratory diseases such as influenza,respiratory syncytial virus (RSV) and inflammatory diseases outside the lung. The FDA and European Medicines Agency have granted AT-100 Orphan Drug Designation.

About Airway Therapeutics

Airway Therapeutics is a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases,beginning with the most vulnerable populations. The company is advancing the novel recombinant human protein hSP-D,a version of an endogenous protein that reduces inflammation and infection in the body while modulating the immune response. AT-100 is Airway's first candidate in development for prevention of BPD in very preterm infants and for treatment of COVID-19 in seriously ill mechanically ventilated patients. To learn more,visit https://www.airwaytherapeutics.com.