Airway Therapeutics Announces FDA Acceptance of IND for AT-100's Second Indication in Severe COVID-19 Patients

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

CINCINNATI,April 12,2021 --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.

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.

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