Respiratory Research Published Phase 1 Trial Results

New findings for the nebulized drug AP02 indicate strong lung concentrations with reduced systemic side effects.

Updated on Sept. 21, 2026 in Asthma

A close-up of a high-tech medical nebulizer device on a clean white surface in a sterile environment. — Respiratory Research announced positive Phase 1 clinical results for its nebulized drug AP02, which showed improved lung delivery compared to oral treatments. AI Illustration. Upload story photo >

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Respiratory Research has published positive results from Phase 1 clinical trials of its nebulized drug AP02. The treatment is being developed to target lung conditions while minimizing systemic exposure compared to current oral medications.

Why it matters

By delivering medication directly to the lungs, AP02 is designed to improve patient tolerability by lowering systemic drug exposure. This approach aims to address the limitations of existing treatments that often cause side effects due to high systemic drug levels.

Phase 1 studies showed AP02 achieved 26-fold higher predicted lung concentration than oral nintedanib at a 4.0 mg dose. Researchers reported no serious adverse events across the study population of 38 total participants.

The players

Respiratory Research

This organization is a biotechnology company focused on developing novel inhaled therapies for respiratory diseases.

Avalyn Pharma

Avalyn Pharma is a clinical-stage biopharmaceutical company that is currently conducting the AURA Phase 2 trial for idiopathic pulmonary fibrosis.

The details

The trials evaluated AP02 in both healthy volunteers and patients with idiopathic pulmonary fibrosis using single and multiple ascending doses up to 8.0 mg. The drug demonstrated superior lung delivery mechanics compared to traditional oral nintedanib administration.

May 2025: Phase 1 topline data presented at the ATS Conference.
September 21, 2026: Respiratory Research published Phase 1 study results.
Late 2027: Topline data expected from the AURA Phase 2 trial.

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The Big Picture

This research follows a pattern set by the AURA Phase 2 trial for idiopathic pulmonary fibrosis as investigators seek to validate targeted delivery mechanisms. The success of this drug candidate could shift treatment standards toward localized inhalation therapies.

Patients with pulmonary conditions may eventually have access to treatments that offer higher lung concentrations with fewer systemic side effects. These findings currently apply to clinical research participants and do not yet alter available pharmacy options.

The takeaway

Advancements in nebulized drug delivery continue to prioritize minimizing systemic side effects while maximizing local therapeutic impact. Researchers remain focused on whether these Phase 1 successes translate into improved long-term patient outcomes.