Beyond Air said the FDA has granted Breakthrough Device Designation to LungFit GO for the treatment of nontuberculous mycobacterial pulmonary disease (NTM-PD).
The Breakthrough Device Designation underscores the need in NTM-PD and builds upon clinical data generated with LungFit GO within this patient population. Results from the company's pilot study, which were published in the peer-reviewed journal Annals of the American Thoracic Society, showed that that adult subjects with chronic refractory NTM lung disease were able to safely self-administer high-dose intermittent inhaled nitric oxide therapy at home, with high treatment compliance and a favorable safety profile. The study also showed signs of meaningful improvement in a subset of patients across quality-of-life domains, along with a trend toward reduced mycobacterial burden, including one instance of culture conversion.
"LungFit GO has the potential to transform nitric oxide from a hospital-based therapy into a practical home-based treatment platform for chronic pulmonary disease and represents a valuable asset within Beyond Air's broader nitric oxide platform," said Robert Goodman, Chief Executive Officer of Beyond Air. "We are excited to receive Breakthrough Device Designation, which validates both the significant unmet need facing patients with NTM-PD and the encouraging clinical experience generated to date with LungFit GO. Our focus and lead resource allocation remain firmly centered on our commercial business, however, this designation enhances the value of LungFit GO and expands the options available to us as we determine the best path forward for the asset, including through enhanced interactions with the FDA."
"While inhaled nitric oxide has been used in medicine for many years, its use has largely been confined to the hospital setting," stated Kenneth Olivier, MD, MPH, Professor of Medicine and Director, Bronchiectasis/NTM Care and Research Center at the University of North Carolina - Chapel Hill. "The ability to deliver high-dose intermittent inhaled nitric oxide through a portable system in the home has the potential to address an important unmet need for patients with NTM-PD, who often require prolonged treatment. Breakthrough Device Designation is an encouraging step toward further evaluating this innovative approach in larger clinical studies."
Beyond Air plans to leverage the enhanced interactions available through the FDA's Breakthrough Devices Program as it finalizes the design of a future clinical study for LungFit GO in NTM-PD. The company believes the designation has the potential to streamline the clinical development process and support more efficient advancement of the program toward potential regulatory approval.
