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Beyond Air Submits Investigational Device Exemption to FDA for the Treatment of COVID-19

PRESS RELEASE

  • LungFit™ BRO system to be used in proposed study to treat COVID-19 patients
  • Grant applications have been submitted to the Biomedical Advance Research and Development Authority (BARDA), a division of Health and Human Services (HHS)
  • Second trial design being vetted to investigate use in patients exposed to severe acute respiratory syndrome 2 (SARS-CoV-2), but not infected

Beyond Air has announced submission of an Investigational Device Exemption (IDE) to the US FDA for use of its LungFit™ BRO system in the treatment of COVID-19 patients. Typically, the FDA responds within 30 days of an IDE submission.

“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 evidence1 points to inhibition of viral replication in a variety of viruses, including coronaviruses, as well as anti-inflammatory properties of nitric oxide,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “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.”

“Nitric oxide therapy at high concentrations is an innovative and potentially ground breaking treatment option against COVID-19. The LungFit™ BRO system is a practical and effective mode of delivery of nitric oxide for both patients and medical teams,” added Andrew Colin, MD, Batchelor Family Professor of Cystic Fibrosis and Paediatric Pulmonology Director, Division of Pediatric Pulmonology Miller School of Medicine University of Miami. “Combating this pandemic is of crucial importance and having the LungFit™ BRO system tested and available as expeditiously as possible should be a priority for all parties.”

COVID-19 Trial Design Highlights

Subject to US FDA approval of its IDE, the company plans to test the LungFit™ BRO for use in the treatment of patients suffering from COVID-19 in an open label study of 75 patients between the ages of 22 and 75 years confirmed with COVID-19 that require hospitalisation. Subjects would be randomised 2:1 and treated with 150 ppm NO administered over 40 minutes, four times per day, in addition to standard of care (SOC) or SOC alone.  The primary endpoint is time to clinical improvement based on key parameters such as fever and oxygen support. Other endpoints include reduction in viral load, fever resolution, oxygen support, hospital length of stay, requirement of mechanical ventilation, mortality, and various biomarkers.  Final trial design is subject to FDA approval of our IDE.

Other protocols targeting people exposed to SARS-CoV-2, the virus that causes COVID-19, are being designed to show that treatment with NO may prevent infection. This can potentially result in a significant decline in the current standard quarantine time of 14 days, protect medical staff treating those with COVID-19 or allow flexibility for the military. Beyond Air will evaluate the path forward for these potential trial design after completion of the first IDE study.

Beyond Air has already generated relevant data in humans. Specifically, in a bronchiolitis study from 2014, 4 out of 43 patients in the study tested positive for coronavirus. The trial was a randomised, double blind, placebo-controlled study designed to compare NO therapy plus SOC versus SOC alone. The study looked at hospital length of stay (LOS) as its primary endpoint.  Of the four non-COVID-19 coronavirus patients, two were in the control arm and two were in the treatment arm, allowing for a post-hoc comparison of the results. The LOS for the 2 patients in the control arm was 60 hours compared to a LOS of 30 hours for the 2 patients in the treatment arm. We believe these results represent a clinically meaningful reduction in LOS.  Additionally, Beyond Air has reported efficacy data from two bronchiolitis studies, and anticipates reporting data from a third study in approximately 8 weeks.  The data reported to date show an approximate one day reduction in LOS.  All infants suffering from bronchiolitis have viral infections.

Safety data from the bronchiolitis studies mentioned above, coupled with other high concentration NO studies, show no NO related serious adverse events (SAEs) with more than 2,000 NO administrations to more than 100 patients.  Additionally, Beyond Air has completed three studies in rats and one in dogs.  There were no macroscopic or microscopic observations in any of these studies.  Two studies lasted 12 weeks and the animals were treated with 250 ppm NO intermittently on a daily basis.  One study lasted 30 days with the top NO concentration of 400 ppm dosed intermittently on a daily basis.  The fourth study provided a clean report for genotoxicity.

LungFit™ BRO Profile

The LungFit™ BRO system weighs 20 lbs and is easy to transport.  All that is required to power the unit is an electrical outlet.  The system is designed to handle up to 240 volts.  Since NO is generated from ambient air, there is an unlimited supply.  For patients who may need supplemental oxygen, the system is designed to accommodate this with a port in the rear of the device.  Nitrogen dioxide (NO2) filters are needed for the system to generate and deliver NO for safety reasons.  Toxic levels of NOcan be a consequence of high concentration NO without proper filtration.  The filters also program the system.  We believe this provides flexibility for NO administration.  The Company is confident that patients can easily be trained to self-administer or if multiple patients are treated in the same facility, one respiratory therapist (RT) can manage at least 10 systems at the same time and each system could treat 4 patients per day.  Each patient would receive 4 administrations of NO per day each lasting 40 minutes separated by 4 hours.  Alarms monitor system performance.  Filters are single-use and there are no special requirements for disposal. Each patient would use their own breathing circuit to avoid contamination.

Beyond Air has ample LungFit™ BRO systems, filters and other equipment necessary to perform the study included in our IDE as well as the second protocol described above.

Link to Press Release

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