-- 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.

Logo - https://mma.prnewswire.com/media/1122328/Airway_Therapeutics_Logo.jpg

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.