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HCPLive Five: Pulmonology Updates at ATS 2026

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5 interviews in 5 minutes. Check out this HCPLive Five at ATS 2026 on late breaking data in sleep apnea, lung function recovery, PAH, lung disease, and COPD.

The 2026 American Thoracic Society (ATS) International Conference in Orlando, Florida, from May 15 – 20, delivered a wave of late-breaking clinical data across pulmonology, sleep medicine, and respiratory infectious disease. In this HCPLive Five, 5 leading physician experts break down the findings clinicians need to know, from the first oral pharmacotherapy for obstructive sleep apnea (OSA) nearing US Food & Drug Administration (FDA) approval to a 55% risk reduction in pulmonary arterial hypertension (PAH) to new frontiers in Mycobacterium avium complex lung disease (MACLD), tuberculosis (TB), and chronic obstructive pulmonary disease (COPD) biologic therapy.

Whether you treat sleep apnea, PAH, nontuberculous mycobacteria, TB, or obstructive lung disease, these 5 interviews cover the phase 3 data shaping the next generation of respiratory care.

AD109 Oral Pill Shows Efficacy for OSA in Phase 3 Trials

AD109 Effective as Oral Agent for Obstructive Sleep Apnea, With Patrick John Strollo, MD

AD109, an investigational once-nightly oral pill combining aroxybutynin and atomoxetine, demonstrated statistically significant efficacy for OSA in the largest pharmacotherapy clinical development program ever conducted for the condition. Pooled phase 3 data from the SynAIRgy and LunAIRo trials, presented by Patrick Strollo, Jr. (University of Pittsburgh) at ATS 2026, showed a 39.3% reduction in apnea-hypopnea index (AHI) versus 12.6% with placebo in CPAP-intolerant adults.

Developer Apnimed has submitted a New Drug Application (NDA) to the FDA, which granted Fast Track designation, with a PDUFA date targeted for Q1 2027.

Novel 4-Month TB Regimen Improves Lung Function Recovery With Sutezolid and NAC

Novel 4-Month Pan-TB Regimens Show Promise for Lung Function Recovery, With Robert Wallis, MD

Novel 4-month pan-TB regimens containing investigational oxazolidinone sutezolid and N-acetylcysteine (NAC) demonstrated improved lung function recovery and fewer adverse events versus standard 6-month HRZE therapy in preliminary phase 2c data from the PanTB-HM trial, presented at ATS 2026. Robert Wallis, MD, chief science officer at the Aurum Institute and professor of medicine at Vanderbilt University, reported a 10.6-point FEV1 improvement at day 14 in patients with impaired baseline pulmonary function. The regimens target both pan-TB treatment without rifampin susceptibility testing and post-TB lung disease, including bronchiectasis, fibrosis, and cavities, a largely overlooked consequence of microbiologic cure affecting at least half of discharged patients.

Ralinepag Reduces Pulmonary Arterial Hypertension Worsening Risk by 55% in Phase 3

Ralinepag Achieves 55% Risk Reduction in PAH, With Vallerie McLaughlin, MD

Ralinepag, an investigational once-daily oral prostacyclin receptor agonist, reduced the risk of clinical worsening in PAH by 55% versus placebo (HR 0.45; P <.0001) in the phase 3 ADVANCE OUTCOMES trial, presented at ATS 2026. Vallerie McLaughlin, MD, director of the pulmonary hypertension program at the University of Michigan, noted ralinepag's higher potency compared to existing agents and its potential for greater prostacyclin pathway activation. Secondary endpoints showed significant NT-proBNP reduction, improved 6-minute walk distance, and 47% greater odds of clinical improvement. United Therapeutics plans an FDA NDA submission in the second half of 2026.

ALIS Achieves 88% Culture Conversion in Newly Diagnosed MAC Lung Disease

ALIS Improves Symptoms in Newly Diagnosed MAC Lung Disease, With Charles Daley, MD

Amikacin liposome inhalation suspension (ALIS) added to guideline-based therapy achieved 88% culture conversion at 6 months and meaningful respiratory symptom improvements in newly diagnosed MACLD, according to phase 3b ENCORE trial data presented at ATS 2026. Charles Daley, MD, of National Jewish Health, said the findings support earlier ALIS initiation rather than reserving it for refractory disease—a shift from current practice.

Itepekimab Cuts COPD Exacerbations in Former Smokers in Phase 3 AERIFY-1 Trial

Phase 3 AERIFY Shows Potential of Itepekimab in COPD, With Klaus F. Rabe, MD, PhD

Itepekimab, an anti–IL-33 monoclonal antibody, reduced annualized moderate-to-severe COPD exacerbation rates by 27.1% in former smokers in the phase 3 AERIFY-1 trial but failed to replicate statistically significant results in the nearly identical AERIFY-2 trial—a discordance Klaus Friedrich Rabe, MD, PhD, of LungenClinic Grosshansdorf, discussed at ATS 2026. Rabe attributed the divergence partly to COVID-19 pandemic-era variability affecting exacerbation rates across study sites.

The investigational biologic targets IL-33-driven airway inflammation outside the type 2 eosinophilic phenotype addressed by existing therapies. Current smokers showed minimal benefit; the phase 3 program was designed primarily around former smokers based on prior phase 2 findings.


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