Beyond Air, Inc. · NASDAQ:XAIR
Beyond Air — Pediatric Academic Societies (PAS) Meeting 2022
15 slides from Beyond Air's conference presentation, 2022
Slide 1: Long-term Effects of Inhaled Nitric Oxide in Infants with Bronchiolitis – A Multi Center Study
Long-term Effects of Inhaled Nitric Oxide in Infants with Bronchiolitis – A Multi Center Study Presenter Name: Prof. Aviv Goldbart Institution: Soroka University Medical center Email:avivgold@bgu.ac.il
Slide 2: Disclosure
Disclosure Prof. Aviv Goldbart • PAS conference participation and travel expenses were supported by Beyond Air Inc. • This study was funded by Beyond Air Inc.
Slide 3: Inhaled Nitric Oxide (iNO) for the treatment of Bronchiolitis
Inhaled Nitric Oxide (iNO) for the treatment of Bronchiolitis • Acute Bronchiolitis • Leading cause of infant hospitalizations, accounting for >120,000 hospitalizations with a direct cost of at least $550 million each year1 • Limited treatment options exist and mainly rely on supportive treatment •
Slide 4: iNO in Bronchiolitis
iNO in Bronchiolitis • Three randomized double blind clinical trials were conducted with high intermittent dose of iNO for acute bronchiolitis. • In these studies, iNO inhalations or Oxygen/air (control) were administered in addition to Standard Supportive Treatment (SST). Number NO dose Study Numbe
Slide 5: iNO in Bronchiolitis Publications
Publications iNO in Bronchiolitis Study 1 NCT01768884 Study 2 NCT03053388 5
Slide 6: Benefits of High Dose iNO Treatment
Benefits of High Dose iNO Treatment Fit for discharge* Hospital Length of Stay (LOS) 1.0 1.0 SST SST 0.9 0.9 0.8 85 ppm NO + SST 0.8 85 ppm NO + SST 150 ppm vs. 85 ppm 150 ppm vs. SST 150 ppm NO + SST 150 ppm NO + SST 0.7 0.7 Hazard Ratio (P-value) Hazard Ratio (P-value) 0.6 0.6 0.5 0.5 Fit for Disc
Slide 7: Short term effect of iNO treatment
Short term effect of iNO treatment • All three studies showed a favorable short term safety profile: • No iNO-treatment related Serious Adverse Events (SAEs) or severe AEs were reported • The incidence level for severe AEs was similar among all groups • Data from previous trials suggest that iNO has
Slide 8: Trial Overview
Trial Overview Study Long-Term, Non-interventional, Multi-center for longitudinal data collection Children who previously participated in three past clinical trials using iNO Participants (treatment) or Oxygen/air (control) for treatment of acute bronchiolitis . Study Measures Data collected based o
Slide 9: Study design
Study design • This non interventional study was Decoding of subjects based on archived information designed to collect longitudinal data about the frequency and cause of Pre-screening (initial contact) hospital readmissions. Informed consent (on-site/telephone) • Data were collected from participan
Slide 10: RESULTS
RESULTS Ce. Academic Societies
Slide 11: Study Population
Study Population • Out of 198 potential participants in 10 potential sites, 101 subjects were enrolled in 6 sites Study 1 (N = 43) Study 2 (N = 68) Study 3 (N = 87) Total enrolled 2013/2014 2017/2018 2019/2020 N enrolled = 13 N enrolled = 29 N enrolled = 59 N enrolled = 101 iNO iNO iNO iNO iNO iNO i
Slide 12: Baseline Demographics
Baseline Demographics 85 ppm 150 ppm iNO + 160 ppm iNO + SST (N=39) Total (N=101) Gender iNO + SST (N=24) SST (N=20) SST (N=18) N % N % N % N % N % Female 14 35.9 13 54.2 6 30.0 6 33.3 39 38.6 Male 25 64.1 11 45.8 14 70.0 12 66.7 62 61.4 Treatment Group/Age at 85 ppm 150 ppm iNO 160 ppm iNO Enrollme
Slide 13: Long Term Safety Profile of iNO
Long Term Safety Profile of iNO Subjects re-hospitalized for bronchiolitis related outcomes Treatment /Control Subjects re- Total Incidence Rate PEY* Rate per 100 PEY • Participants’ re-hospitalization rate per 100 Group hospitalized Subjects (95%CI) (95%CI) Patient Exposure Years (PEY), due to (N)
Slide 14: In summary
In summary • Our studies have suggested benefits of iNO treatment for bronchiolitis demonstrated by a shorter Length of Hospital Stay (LOS) and shorter time of oxygen dependence (Time to room air SaO2≥92%) • Short term safety effects of iNO in acute bronchiolitis (up to 30 days) showed no drug relat
Slide 15: Thank You – Q&As
Thank You Q&As avivgold@bgu.ac.il Your Institution or Hospital Logo Here
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