Company: XAIR
Filing Date: 2025-02-10
Form Type: 10-Q
Source: 0001493152-25-005678
Chunk: 160

Company: Beyond Air, Inc.
Filing Date: 2025-02-10
Form: 10-Q
Item: Part I, Item 2
Chunk 160
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 at the ATS International Conference 2021, which was held virtually from May 14, 2021 through May 19, 2021. Analysis across
the studies (n=198 infants, mean age 3.9 months) showed that 150 ppm – 160 ppm NO administered intermittently was generally safe
and well tolerated with adverse event rates similar among treatment groups with no reported treatment-related serious adverse events.
The short course of treatments with intermittent high concentration inhaled NO was effective in shortening hospital LOS and accelerating
time to fit for discharge – a composite endpoint of clinical signs and symptoms to indicate readiness to be evaluated for hospital
discharge. This treatment was also effective in accelerating time to stable oxygen saturation – measured as SpO2 ≥ 92% in room
air. Additionally, NO at a dose of 85 ppm NO showed no difference compared to control for all efficacy endpoints, while 150 ppm NO showed
statistical significance when compared to control.

 29 

Additionally,
long-term safety data for high concentration inhaled NO in bronchiolitis was presented at the Pediatric Academic Societies Meeting 2022
(PAS 22), which was held in Denver, Colorado from April 21, 2022 through April 25, 2022. A total of 101 infants from the three prior
pilot studies for bronchiolitis (n=198) participated in the long-term follow-up clinical trial. Clinical trial endpoints for the long-term
safety clinical trial included percentage of patients re-hospitalized for bronchiolitis related reasons, such reasons included wheezing
episodes, pneumonia, and asthma and the percentage of patients re-hospitalized for any reason. Data from the clinical trial showed the
re-hospitalization rate per 100 Patient Exposure Years (PEY) due to bronchiolitis related reasons trended favorably for the inhaled NO
group. In addition, the long-term patient re-hospitalization rate for any reason was similar between inhaled NO and control groups. As
such, the clinical trial concluded that the treatment of hospitalized infants with acute bronchiolitis by intermittent high dose inhaled
NO shows a favorable long-term safety profile.

We
believe that the entirety of data at 150 ppm – 160 ppm NO in both adult and infant patient populations supports further development
of LungFit® PRO in a pivotal clinical trial for patients hospitalized with VCAP or bronchiolitis.

LungFit®
GO for