FDA accepts Airway’s IND to develop novel recombinant protein for COVID-19

The US FDA has accepted Airway Therapeutics’ Investigational New Drug (IND) application to develop AT-100 (rhSP-D) as a treatment for COVID-19.

Cincinnati biopharmaceutical company, Airway Therapeutics 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, 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.

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