On May 26, 2020, Beyond Air, Inc.(NASDAQ:XAIR) announced that it had received approval from Health Canada to study nitric oxide generated and delivered by its LungFit™ system in COVID-19 patients.
The Canadian COVID-19 study is bifurcated. Part 1 will assess safety at 80 parts per million (ppm) NO, and then, upon the recommendation of a data safety monitoring board (DSMB), Part 2 will begin, which is designed to assess safety and efficacy at 150 ppm NO.
● Part 1 will enroll 10 adult patients hospitalized with COVID-19 in a single arm dosed intermittently with 80 ppm NO four times per day for 40 minutes each plus standard supportive therapy (SST) for up to seven days. ● Part 2 will enroll 40 adult patients hospitalized with COVID-19, randomized 1:1, to receive either SST or SST plus 150 ppm NO dosed intermittently four times per day for 40 minutes each for up to seven days. The primary endpoint is time to clinical deterioration as measured by the need for: 1) non-invasive ventilation; or 2) high flow nasal canula; or 3) intubation or death. Other endpoints include reduction in viral load, need for supplemental oxygen, hospital length of stay, safety and various biomarkers.
“The Beyond Air team continues to execute and advance the LungFit system toward regulatory approvals around the world to treat severe lung infections and pulmonary hypertension. We are thankful to Health Canada for working so diligently with us to get to this point with our COVID-19 program. We will certainly move as quickly as possible to complete this study to show the safety and potential efficacy of the LungFit system in delivering high concentration nitric oxide to treat this patient population,” said Steve Lisi, Chairman and CEO of Beyond Air.
Beyond Air stock price has been trying to make a breakthrough for the last 3 years to no avail. Will this help our XAIR stock investors regain trust with Beyond Air? It all depends of how big this news is, having in mind that COVID-19 crisis is almost behind us.