PR95268

MARIETTA, Ga., March 31, 2022 /PRNewswire=KYODO JBN/ --

-- Novel preventative AT-100 offers potential to reduce incidence and severity

of serious respiratory disease BPD, improving outcomes in very preterm infants

Airway Therapeutics (https://c212.net/c/link/?t=0&l=en&o=3489603-1&h=4231491452&u=https%3A%2F%2Fwww.airwaytherapeutics.com%2F&a=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.

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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.D., 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 www.clinicaltrials.gov identifier: NCT04662151

(https://c212.net/c/link/?t=0&l=en&o=3489603-1&h=1798378327&u=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04662151%3Fterm%3DAirway%2BTherapeutics%26draw%3D2%26rank%3D2&a=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(https://c212.net/c/link/?t=0&l=en&o=3489603-1&h=2929251015&u=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT04659122%3Fterm%3DAirway%2BTherapeutics%26draw%3D2%26rank%3D1&a=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.  

SOURCE: Airway Therapeutics, Inc.

CONTACT: Meghan Riley, riley@airwaytherapeutics.com