PR88703

CINCINNATI, March 26, 2021 /PRNewswire=KYODO JBN/ --

-- Initiating Phase 1b randomized clinical trial with initial results expected

in late 2021

-- Potential for novel, preventive AT-100 to reduce incidence and severity of

serious respiratory disease BPD, improving outcomes and survival in very

preterm infants

Airway Therapeutics (

https://c212.net/c/link/?t=0&l=en&o=3109631-1&h=1712657884&u=https%3A%2F%2Fwww.airwaytherapeutics.com%2F&a=Airway+Therapeutics

), Inc., a biopharmaceutical company developing a new class of biologics to

break the cycle of injury and inflammation for patients with respiratory and

inflammatory diseases, today announced the U.S. Food and Drug Administration

(FDA) has accepted its Investigational New Drug (IND) application to develop

AT-100 (rhSP-D) as a preventive treatment for the serious respiratory disease

BPD in very preterm babies.

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Airway will initiate a Phase 1b randomized clinical trial to confirm the

feasibility of intra-tracheal administration of AT-100 and its beneficial

safety and tolerability profile. The Phase 1b trial will be followed by a

randomized pivotal trial with preliminary results expected as soon as second

half 2023.

"Preterm infants with BPD have higher mortality, and those who survive suffer

from lifelong chronic consequences. With no approved treatments for BPD, AT-100

has potential to reduce incidence and severity of BPD, related short- and

long-term consequences, and ultimately improve the survival of these vulnerable

patients," said Marc Salzberg, M.D., CEO of Airway. "We are excited to advance

this new therapy into the clinic with the potential to deliver novel therapies

for patients in desperate need of new treatment options."

AT-100 is a novel human recombinant protein – an engineered version of an

endogenous protein -- that has been shown in preclinical studies to reduce

inflammation and infection triggered in very preterm babies, by mechanical

ventilation and oxygen support, and ultimately reduce the onset of lung damage.

Very preterm infants whose lungs are not fully developed must be intubated and

ventilated to enable breathing. Although the mechanical ventilation preserves

life, it can damage fragile lung tissue, causing inflammation and infection

which can result in the arrest of lung development, and ultimately BPD.

Airway has filed an additional IND application with the FDA for AT-100 for

treatment of COVID-19. In addition to its anti-inflammatory properties,

preclinical studies of AT-100 have shown potential to inhibit SARS-CoV-2

replication and promote viral elimination. AT-100 may also reduce secondary

infections in mechanically ventilated COVID-19 patients. This multidimensional

approach differentiates AT-100 from other COVID-19 treatments in development.

About AT-100

AT-100 is a novel recombinant human protein rhSP-D, an engineered version of an

endogenous 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

rhSP-D, an engineered 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