Inhaled Therapy Showed Potential for Lung Fibrosis Treatment
A new nebulized drug may treat pulmonary fibrosis with lower systemic side effects than current oral options.
Updated on Sept. 21, 2026 in Asthma
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Researchers have published Phase 1 clinical trial results for AP02, an inhaled medication being developed to treat idiopathic pulmonary fibrosis. The study demonstrated the drug's safety in healthy volunteers and patients, moving it toward further testing.
Why it matters
Current treatments for lung fibrosis are often oral, which can lead to higher systemic exposure and side effects. This new delivery method aims to concentrate the medication directly in the lungs to improve tolerability for patients.
In Phase 1 studies of 32 healthy volunteers and 6 patients with idiopathic pulmonary fibrosis, AP02 was tested in doses up to 8.0 mg. The study reported no serious adverse events, suggesting a favorable safety profile compared to traditional oral medications.
The players
Respiratory Research
A research entity focused on the development of nebulized pulmonary therapies.
Avalyn Pharma
A biopharmaceutical company currently conducting Phase 2 trials for pulmonary fibrosis treatments.
The details
AP02 is delivered via nebulizer, allowing the medication to reach the lungs directly. This approach achieved significantly higher predicted lung concentrations compared to a standard 150 mg oral dose of nintedanib. By localizing the drug in the lung tissue, it reduces the amount of medication that circulates through the rest of the body, which may minimize common treatment side effects.
Timeline
May 2025: Phase 1 topline data were presented at the ATS Conference.
September 21, 2026: Respiratory Research published the final Phase 1 study results.
Late 2027: Topline data are expected from the ongoing AURA Phase 2 trial.
Health Landscape
The development of nebulized therapies represents a shift toward targeted pulmonary delivery in the treatment of idiopathic pulmonary fibrosis. This approach contrasts with the traditional systemic delivery of oral nintedanib to minimize side effects while maintaining therapeutic efficacy.
Patients currently managing lung fibrosis should keep an eye on clinical trial advancements as researchers explore new ways to reduce systemic drug exposure. Any questions regarding changes to treatment protocols or the suitability of future therapies should be directed to your pulmonologist.
The takeaway
AP02 is a promising new approach to lung medication that targets the lungs directly to potentially reduce total-body drug exposure. Patients should continue their current prescribed treatment plans and discuss emerging clinical trials with their physician to see if they may be candidates for future studies.
What happens next
Avalyn Pharma anticipates the release of topline data from the 12-week AURA Phase 2 clinical trial in late 2027.
Further reading
For more on evolving treatment delivery methods for respiratory conditions, visit the Asthma section.
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