More than 70% of IPF patients receiving inhaled pirfenidone achieved stabilization or improvement in fibrosis scores at 24 weeks.
RT’s Three Key Takeaways:
- Imaging Correlation: New data demonstrate that improvements in quantitative lung imaging correlate with lung function and quality of life outcomes in patients with idiopathic pulmonary fibrosis.
- Fibrosis Stabilization: More than 70% of patients receiving inhaled pirfenidone achieved stabilization or improvement in fibrosis scores at 24 weeks, according to trial results.
- Rapid Benefits: Patients with documented improvements in lung imaging experienced clinically meaningful quality of life gains as early as week 8 of treatment.
Avalyn Pharma announced the publication of peer-reviewed data in BMC Pulmonary Medicine demonstrating that improvements in quantitative lung imaging correlate with lung function and quality of life in patients with idiopathic pulmonary fibrosis (IPF) treated with AP01. The findings represent the first dataset for an antifibrotic therapy to show a correlation between quantitative high-resolution computed tomography (HRCT) imaging, changes in lung function measures, and patient-reported quality of life (QOL) outcomes, according to a news release.
The analysis used post-hoc data from the ATLAS Phase 1b trial and incorporated advanced quantitative imaging in collaboration with the Department of Radiology at the University of California, Los Angeles (UCLA). Results indicated that more than 70% of patients who received 100 mg of AP01 (inhaled pirfenidone) twice daily achieved stabilization or improvement in their HRCT fibrosis score at week 24. Some participants also showed reductions in fibrotic volume and increases in whole lung volume.
“Our quantitative CT imaging analysis suggest that inhaled AP01 may help stabilize lung fibrosis, and the results show early signals consistent with potential improvement of interstitial lung disease, alongside with encouraging trends in lung function and patients’ daily lives,” said Jonathan Goldin, MD, PhD, senior author and professor-in-residence of radiological science, medicine & physics, and biology in medicine program at UCLA, in a news release. Goldin added that the ability to measure distinct patterns of fibrosis response represents a new paradigm in future patient care.
The publication also reported dose-dependent reductions in quantitative ground glass (QGG), a marker associated with early fibrosis or potentially reversible lung injury. Quantitative analysis confirmed that patients with HRCT-documented fibrosis improvement experienced the most rapid QOL gains, with benefits observed as early as week 8 and sustained through week 48.
“The findings from this seminal analysis mark a true trifecta of potential benefits for people living with IPF,” said Howard Lazarus, MD, FCCP, chief medical officer of Avalyn, in a news release. Lazarus noted the treatment could mean not only slowing fibrosis progression but also improving how patients function in their daily lives.
AP01 is an optimized inhaled formulation of pirfenidone, a small molecule inhibitor with anti-inflammatory and anti-fibrotic effects. The medication is delivered to the lungs in less than 10 minutes using the PARI eFlow Nebulizer System. These findings provide multi-dimensional insights that healthcare providers have been seeking for better disease management.
“By demonstrating that these physiologic fibrosis and quality-of-life improvements can occur together with AP01, we are providing the kind of multi-dimensional insights that clinicians have been seeking,” said Lyn Baranowski, chief executive officer of Avalyn, in a news release.
Avalyn is currently evaluating AP01 in the global MIST Phase 2b trial for patients with progressive pulmonary fibrosis (PPF). The company is also conducting the AURA Phase 2 trial of AP02, an inhaled nintedanib, in patients with IPF. Both trials will prospectively incorporate HRCT imaging to further validate these findings. AP01 is an investigational therapy and is not approved by the US Food and Drug Administration (FDA).
