Beyond Air Inc will initiate a clinical study of its LungFit tankless nitric oxide (NO) system for evaluation of the safety and efficacy of high concentration inhaled NO given intermittently to adults hospitalized with acute viral pneumonia, including SARS-CoV-2.
The LungFit system uses proprietary technology to generate nitric oxide from ambient air. The device is portable, weighs only 20 lbs, and operates with a standard electrical outlet (120-240 volts). Since NO is generated from ambient air that flows through a reaction chamber, there is an unlimited supply, the company says. The LungFit system is designed to accommodate simultaneous oxygen delivery for patients who require it via a dedicated port in the rear of the device.
The study will take place in Israel and be a multi-center, open-label, randomized clinical trial with approximately 90 adult patients. The enrolled patients will be randomized in a 1:1 ratio to receive inhalations of 150 ppm NO given intermittently for 40 minutes four times per day for up to seven days in addition to standard supportive treatment (NO+SST); or standard supportive treatment alone (SST). Endpoints related to safety, oxygen saturation, fever and ICU admission, among others, will be assessed.
“Initiating this pilot study in patients hospitalized with acute viral pneumonia is another important step towards establishing the broad-spectrum anti-microbial activity of nitric oxide,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “The study will enroll subjects with any virus, with an emphasis on SARS-CoV-2 infections. Our LungFit system is poised to transform the way we treat lung infections by generating nitric oxide from ambient air and safely delivering it to patients’ lungs.”
“As the COVID-19 pandemic is nowhere near its end, the scientific and medical communities are fearful of the upcoming winter, and the possibility of patients with co-infections of SARS-COV-2 with the flu or RSV,” said Prof. Talya Wolak, head of Internal Medicine Department D and head of the COVID-19 unit at Shaare Zedek Medical Center (Jerusalem, Israel). ”We are eager for a treatment to minimize the effect of co-infection, and to treat our patients safely and effectively. Beyond Air’s upcoming trial, with previously announced positive safety and efficacy data in other viral infections, could be efficient in the treatment of those patients.”
Beyond Air’s proprietary nitrogen dioxide (NO2) filters are required for the system to generate and safely deliver NO. Toxic levels of NO2 can result from high concentrations of NO without proper filtration. The filters also program the system, via an attached RFID chip, with NO concentration, flow rate and duration. The Company believes this provides flexibility for NO administration. The Company is confident that respiratory therapists (RTs) can easily be trained to use and manage the system. If multiple patients are treated in the same facility, one RT could manage multiple systems simultaneously, with each system potentially treating up to four patients per day. Filters are single patient use and there are no special requirements for disposal. Alarms monitor system performance.