Prior May 2020, Airway Therapeutics filed a pre-IND submission with the US FDA for AT 100 as a preventive treatment for bronchopulmonary dysplasia (BPD) in very preterm infants  .
In March 2020, Airway Therapeutics announced filling with the Respiratory Diseases Branch of the National Institutes of Health (NIH) to evaluate AT 100, for the treatment of COVID-19 infection  .
In March 2017, Airway Therapeutics announced its intention to file an investigational new drug application to initiate a clinical proof of concept trial of AT 100 in bronchopulmonary dysplasia and in other lung related disorders  . An IND for AT 100 in combination with an existing surfactant was expected to be filed with the FDA in the fourth quarter of 2012. The company was in discussion with one of a surfactant manufacturer as of June 2011  .
Preclinical data suggested that AT 100, in addition to commercially available surfactant, effectively prevents the infection, reduces inflammation and lung damage compared to current standard of care  . AT 100 also modulates immune system  .
The US FDA and the EMA granted orphan drug designation to AT 100 for the prevention of bronchopulmonary dysplasia  .
In January 2020, Airway Therapeutics received a oversubscribed series C financing worth $US 15.5 million, the proceeds of which will be used for the clinical development of AT 100 for the preventive treatment of serious respiratory disease bronchopulmonary dysplasia (BPD) in very preterm infants, while also supporting preclinical research in influenza, respiratory syncytial virus (RSV) and cystic fibrosis. The funding will also enable further development its preclinical package for influenza, RSV and cystic fibrosis  .
In March 2017, Airway Therapeutics received a funding of $US6.3 million as a part of bridge financing from new and existing investors including Cincinnati Children’s Hospital Medical Center, CincyTech and Queen City Angels. The company plans to utilise the funds for the development of AT 100 which includes, manufacturing, IND enabling studies and clinical proof of concept trials  .
In September 2014, Airway Therapeutics secured $US4.6 million in Series A financing. The company will use proceeds for the development of AT 100, including formulation, manufacturing and designing preclinical studies required in preparation for clinical studies  .