PR88944

CINCINNATI, Apr. 12, 2021 /PRNewswire=KYODO JBN/ --

-- Initiating Phase 1b clinical trial with initial results expected 3Q2021

-- Potential for novel therapeutic AT-100 to inhibit viral replication, promote

viral elimination and reduction of lung injury, inflammation, and secondary

infections in severe COVID-19 patients

Airway Therapeutics (

https://c212.net/c/link/?t=0&l=en&o=3124414-1&h=2220446592&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 treatment for COVID-19. Airway is leveraging the FDA's

Coronavirus Treatment Acceleration Program (CTAP) that is aimed at evaluating

new treatment options for COVID-19.

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

intratracheal administrations of AT-100 and its beneficial safety and

tolerability profile.

Airway's novel human recombinant protein AT-100 – an engineered version of an

endogenous protein – has been shown in preclinical studies to safely reduce

inflammation and infection while modulating the immune response across a range

of respiratory diseases inside and outside the lung.  Additionally, 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

severe COVID-19 patients who are mechanically ventilated in intensive care.

This multidimensional approach differentiates AT-100 from other COVID-19

treatments in development.

"The pre-clinical data are encouraging and lead us to believe that AT-100 has

therapeutic potential against COVID-19 by reducing infection and inflammation

in mechanically ventilated seriously-ill patients who require a range of

treatment options," said Marc Salzberg, M.D., CEO of Airway. "We are excited to

advance the clinical development of AT-100 with the goal of delivering a novel

therapy for severely ill COVID-19 patients who are in need of new treatment

options."

In March, the FDA approved Airway's first IND application to develop AT-100 as

a preventive treatment for the serious respiratory disease bronchopulmonary

dysplasia (BPD) in very preterm infants. The Phase 1b clinical trial will begin

later this month.

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.