Beyond Air Inc will receive up to $2.17 million in funding from the Cystic Fibrosis Foundation to help fund an ongoing study of the company’s LungFit Go NTM pilot trial, which is testing the use of high concentration inhaled nitric oxide (iNO) for the treatment of Nontuberculous Mycobacteria Pulmonary Disease (NTM).
The study is an at-home, 12-week, single arm, multi-center pilot trial in Australia, which is expected to enroll approximately 20 CF or non-CF bronchiectasis patients with refractory Mycobacterium avium complex (MAC) or Mycobacterium abscessus complex (MABSC) lung infections.
After an initial run-in period that provides a baseline for efficacy endpoints, patients are titrated from 150 parts per million (ppm) up to a maximum of 250 ppm NO over several days in the hospital. During this phase, patients will receive NO for 40 minutes, four times per day. Patients will be trained to use LungFit Go in the hospital and subsequently discharged to complete the remaining portion of the initial two-week treatment phase at their home at the highest tolerated NO concentration.
For the second treatment phase, a 10-week maintenance period, patients will self-administer the 40-minute treatments twice daily at home. The study will evaluate parameters including safety, quality of life, physical function, and bacterial load, as compared to baseline measurements. In addition, NO treatment-mediated changes in the antibiotic susceptibility and gene expression of NTM bacteria in patient sputum will be characterized.
“We are grateful to receive funding support from the Cystic Fibrosis Foundation toward a shared goal of improving the lives of people living with cystic fibrosis. To date, our NTM program has produced data from four compassionate use patients and nine patients from a previous pilot study — all suffering from refractory MABSC infection with underlying CF. If our ongoing at-home pilot trial is successful, we believe that LungFit Go has the potential to improve the lives of patients suffering with NTM lung infection by bringing high concentration nitric oxide to the home,” said Steve Lisi, chairman and Chief Executive Officer of Beyond Air.
Beyond Air expects to report interim data around the middle of calendar year 2021, which will be followed by topline data approximately six months later.