Airway Therapeutics Opens International Clinical Trial Sites and Treats First Patient in Spain in Phase 1b Study of Zelpultide Alfa (AT-100) in Preterm Infants at Risk for Bronchopulmonary Dysplasia (BPD)

Further plans for expansion in Europe include up to ten clinical trial sites across Spain by end of Q32022 and up to three sites in Italy by end of 2022

Zelpultide alfa has been approved as the generic name for our AT-100 (rhSP-D) by the two governing organizations, the United States Adopted Names (USAN) Council and the World Health Organization (WHO) INN Programme

MARIETTA, Ga., Oct. 3, 2022 /PRNewswire/ -- 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 the first patient dosed in Spain in its ongoing Phase 1b Trial of zelpultide alfa (rhSP-D) for preventative use in very preterm infants at risk for bronchopulmonary dysplasia (BPD). Already active in 10 sites in the U.S., Airway's Europe expansion allows for broader study and accessibility of zelpultide alfa as a potential anti-inflammatory and anti-infective preventative therapy for the serious respiratory disease BPD. In addition to BPD, zelpultide alfa is being studied in an ongoing phase 1b clinical trial for COVID in the U.S.

Each year, 2.5 million very preterm infants are at risk of contracting BPD around the world. Infants with BPD have a higher risk of fatality and chronic complications throughout life, including recurring pneumonia, asthma, and neurodevelopment challenges. BPD is a serious respiratory condition which often occurs in very preterm infants who are born without fully developed lungs and requires mechanical ventilation. Up to 80 percent of infants born before 27 weeks of gestational age require respiratory support to live. Though these interventions preserve life, they can damage delicate lung tissue, causing inflammation and infection and result in scarring and susceptibility to infections and diseases, including BPD.

"Despite its global prevalence, treatment options for BPD remain very limited. At Airway, we strive to reduce the incidence, severity, and long-term effects of BPD in as many patients as possible," said Marc Salzberg, M.D., CEO.  "In Spain, we received approval for the expansion of the Phase 1b trial for zelpultide alfa to patients outside the United States. This is an integral step toward understanding the potential of zelpultide alfa in very preterm infants, with the goal of making our novel therapy accessible globally."

"Preclinical studies of zelpultide alfa demonstrate the promise of the potential therapy above the current standard of care. I am proud to partner with Airway to begin studying the potential of zelpultide alfa in qualifying very preterm infants in Spain with the goal of improving the short- and long-term outcomes for these fragile babies," said Máximo Vento, Ph.D., M.D., Division of Neonatology, and Clinical Trial Site Leader at Spain's University and Polytechnic Hospital La Fe in Valencia, Spain.

About Zelpultide Alfa

Zelpultide alfa (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 zelpultide alfa for the prevention of BPD in very preterm born babies and as a therapeutic for seriously ill COVID-19 patients. Zelpultide alfa'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 zelpultide alfa Orphan Drug Designation.

About Airway Therapeutics

Airway Therapeutics, Inc. 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. Their current randomized, blinded Phase 1b study of zelpultide alfa is currently enrolling very prematurely born infants requiring mechanical ventilation. The clinical trial will confirm the feasibility of intratracheal administration of zelpultide alfa in a randomized dose escalation study designed to evaluate the safety and tolerability in 36 patients. Airway anticipates preliminary data from its Phase 1 b study in 1Q2023. For more information about the trial, refer to the clinicaltrials.gov identifier: NCT04662151.

Zelpultide alfa is Airway's first candidate in development for prevention of BPD in very preterm infants. Concurrently, Airway is conducting a Phase 1b study for treatment of seriously ill COVID-19, requiring mechanical ventilation. To learn more, visit https://www.airwaytherapeutics.com.  

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