Beyond Air said that it has submitted an investigational device exemption (IDE) to the FDA seeking to use its cylinder-free LungFit BRO inhaled nitric oxide (iNO) delivery system for the treatment of COVID-19. Beyond Air has been developing the LungFit BRO system for the treatment of bronchiolitis.
The company said that if the FDA approves the IDE, it will conduct an open label study of iNO delivered via LungFit BRO in addition to standard of care in 75 patients hospitalized due to COVID-19. In addition, the company is making plans to test its iNO for the prevention of SARS-CoV-2 infection after evaluating the results of the first trial.
Beyond Air Chairman and CEO Steve Lisi commented, “There is a mounting body of evidence that inhaled NO, including NO generated and delivered by our LungFit BRO system, is safe and well-tolerated in animals and in human subjects at concentrations of 150 ppm and higher. In vitro evidence points to inhibition of viral replication in a variety of viruses, including coronaviruses, as well as anti-inflammatory properties of nitric oxide. We believe that our LungFit BRO system may, given the three completed pilot clinical studies in bronchiolitis, be a significant tool in the battle against this coronavirus that has reached global pandemic status. In response to the unprecedented nature of the COVID-19 situation, Beyond Air is taking all necessary steps to make this potential solution available as quickly as possible to ensure that clinicians have access to NO therapy as a treatment option.”
Read the Beyond Air press release.
