Avalyn Pharma presented recent data from an open-label extension (OLE) study that support the potential of inhaled pirfenidone, AP01, to preserve forced vital capacity (FVC) in individuals with various forms of pulmonary fibrosis.

The new data, reported at the European Respiratory Society (ERS) Congress, was derived from the ongoing AP01-005 OLE study, which followed the successful phase 1b ATLAS study focused on patients with idiopathic pulmonary fibrosis (IPF).

“The consistent trend towards stabilization of lung function across the ATLAS and AP01-005 studies indicate to us that AP01 is reaching the lungs with sufficient concentrations and is having the intended effect in participants with both idiopathic and progressive forms of pulmonary fibrosis,” explained Howard M. Lazarus, MD, FCCP, chief medical officer at Avalyn.

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“These efficacy results, combined with the continued strong tolerability profile across patient populations support our continued clinical development of AP01 in adults with pulmonary fibrosis.”

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Key highlights of the presentations included:

  • Alex West, MD, interstitial lung disease lead at Guy’s and St Thomas’ Hospital in London and investigator in the ATLAS study, presented 48-week results from the AP01-005 study, revealing that patients with IPF treated with AP01 experienced a less significant reduction in FVC compared with those treated with oral pirfenidone. In addition, adults receiving AP01 reported significantly lower rates of side effects, including nausea, rash, diarrhea, dyspepsia, and vomiting compared with the side-effect profile associated with oral pirfenidone. The most commonly reported adverse event among participants in both the ATLAS and AP01-005 studies was a mild cough.
  • Nazia Chaudhuri, MD, consultant in respiratory medicine at the Ulster University School of Medicine in Ireland and investigator in the ATLAS and AP01-005 studies, presented findings from a meta-analysis in a late-breaking poster. This analysis compared FVC outcomes of patients with IPF enrolled in the ATLAS study with pooled placebo results from 4 published studies of oral pirfenidone and oral nintedanib in adults with IPF. The analysis indicated that AP01 (administered at 100 mg, twice daily) demonstrated superior efficacy compared with placebo.

In addition, Dr. West presented a poster comparing AP01-005 findings in patients with progressive pulmonary fibrosis (PPF) with published results from patients with PPF treated with oral nintedanib, currently the only approved medication for PPF.

Avalyn Pharma expects to announce its next steps in the clinical development of AP01 in the coming months.


Avalyn Pharma presents data showing favorable tolerability and potential of AP01 to preserve forced vital capacity in adults with pulmonary fibrosis. News release. Avalyn Pharma Inc.; September 12, 2023.