Press Releases May 21, 2026 08:00 AM

Avalyn Announces Additional Long-term Data on AP01, Inhaled Pirfenidone, for the Treatment of Pulmonary Fibrosis to be Presented at the European Alliance of Associations for Rheumatology 2026

Avalyn Pharma to Present Promising Long-term Data on Inhaled Pirfenidone for Pulmonary Fibrosis at EULAR 2026

By Jordan Park AVLN

Avalyn Pharma announced upcoming presentation of four-year long-term data from their ATLAS open-label extension trial on AP01, an inhaled formulation of pirfenidone, for treating progressive pulmonary fibrosis. The data highlights tolerability and potential to preserve lung function, supporting their Phase 2b clinical development program. Avalyn is also advancing additional inhaled antifibrotic therapies, aiming to transform pulmonary fibrosis treatment.

Avalyn Announces Additional Long-term Data on AP01, Inhaled Pirfenidone, for the Treatment of Pulmonary Fibrosis to be Presented at the European Alliance of Associations for Rheumatology 2026
AVLN

Key Points

  • Long-term data up to four years showing tolerability of AP01 in progressive pulmonary fibrosis patients.
  • AP01 is an inhaled pirfenidone formulation designed to improve lung delivery and reduce systemic side effects compared to oral therapy.
  • Avalyn is advancing multiple inhaled antifibrotic candidates (AP01, AP02, AP03) targeting serious rare respiratory diseases.
  • Impacted sectors include biotechnology, pharmaceuticals (respiratory and rare disease treatments), and healthcare markets focused on pulmonary fibrosis and interstitial lung diseases.

BOSTON, May 21, 2026 (GLOBE NEWSWIRE) -- Avalyn Pharma Inc. (Nasdaq: AVLN), a clinical-stage biopharmaceutical company pioneering inhaled therapies to transform the treatment paradigm of serious, rare respiratory diseases, today announced an upcoming poster presentation at the European Alliance of Associations for Rheumatology (EULAR) 2026, being held June 3-6, 2026, in London, England.

Updated findings from the ATLAS open-label extension trial will highlight the long-term tolerability profile of AP01 (inhaled pirfenidone) among the cohort of patients with progressive pulmonary fibrosis at up to four years of treatment. See the EULAR online program for more details. The presentation will also be accessible on the company’s website.

EULAR 2026 Poster Presentation Details:

Title: Nebulized pirfenidone (AP01) for progressive pulmonary fibrosis in connective tissue disease-associated and other interstitial lung diseases: 4-year data from the ATLAS open label extension trial
Session: Poster View VIII, Saturday, June 6, 10:15 BST. Poster ID: POS1150
Speaker: Prof. Anna-Maria Hoffmann-Vold, Oslo University Hospital and University Hospital Zurich
Authors: Anna-Maria Hoffmann-Vold, Felix Woodhead, Nazia Chaudhuri, Deepthi Nair, Shailendra Menjoge, Hao Bao, Meredith Hart, Howard M. Lazarus, Craig Conoscenti

About Avalyn Pharma
Avalyn aims to transform the treatment paradigm for pulmonary fibrosis and other serious, rare respiratory diseases. The company is advancing optimized inhaled formulations of established antifibrotic medicines designed to deliver drug directly to the lungs, enhance local efficacy, and reduce systemic side effects. Avalyn’s AP01 program is an optimized inhaled formulation of pirfenidone currently being evaluated in MIST, a global Phase 2b clinical trial in patients with progressive pulmonary fibrosis (PPF). AP01 has indicated encouraging safety and clinical activity across Phase 1b and multi-year open-label extension trials, with long-term data supporting the potential to preserve lung function while improving tolerability relative to historical oral pirfenidone. Avalyn’s AP02 program is an optimized inhaled formulation of nintedanib currently being evaluated in AURA-IPF, a global Phase 2 clinical trial in patients with idiopathic pulmonary fibrosis (IPF). Avalyn is also advancing AP03, an inhaled fixed-dose combination of pirfenidone and nintedanib, designed to deliver multiple antifibrotic mechanisms through a single lung-targeted platform. By leveraging its proprietary drug-device approach and deep expertise in rare respiratory disease development, Avalyn aims to establish a new standard of care in pulmonary fibrosis through inhaled, lung-targeted therapies. For more information, please visit avalynpharma.com and follow the company on LinkedIn.

Investor Contact:
Cassie Saitow, Avalyn Pharma Inc.
Sr. Director, IR and Corporate Communications
[email protected]

Media Contact:
Kat Lippincott, Deerfield Group
[email protected]
[email protected]


Risks

  • Clinical trial risks including failure to confirm efficacy or safety in ongoing Phase 2b trials for AP01 and other candidates.
  • Regulatory approval uncertainty for inhaled antifibrotic drugs targeting pulmonary fibrosis markets.
  • Market adoption risks associated with new treatment paradigms and competition from existing oral therapies and pipeline entrants.

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