Avalyn Presents Data from its AP01 and AP02 Inhaled Therapeutics Programs for Pulmonary Fibrosis

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Preclinical data that supported initiation of the completed Phase 1a AP02 inhaled nintedanib study to be presented for the first time at the PFF Summit

AP01 inhaled pirfenidone clinical data, including safety and tolerability in the Phase 1b ATLAS trial and open-label extension, will also be highlighted

SEATTLE – Nov. 9, 2023 Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted inhalation therapies for life-threatening pulmonary diseases, today announced the presentation of preclinical data that supported the completed Phase 1a trial of AP02 (inhaled nintedanib) as well as clinical data for AP01 (inhaled pirfenidone) at the 2023 Pulmonary Fibrosis Foundation (PFF) Summit at the JW Marriott Grande Lakes in Orlando, FL.

“We are excited to engage with the pulmonary fibrosis community at the PFF Summit, including people living with the disease, their caregivers and the expert providers that support them, and to share data for our inhaled treatment candidates AP01 and AP02,” said Howard M. Lazarus, M.D. FCCP, Avalyn’s chief medical officer. “We are eager to advance clinical development of both AP01 and AP02 candidates for pulmonary fibrosis, a fatal disease in which less than a third of patients in the U.S. are treated with currently available oral treatments due to tolerability challenges. Based on the totality of clinical and preclinical data for these programs, we continue to believe that our inhaled therapeutic candidates offer the potential for improved tolerability and efficacy profiles with optimized delivery to the lungs.”

Avalyn’s AP02-related poster presentation will outline findings with inhaled nintedanib in a human-predictive preclinical model. These data demonstrated that inhaled nintedanib was well-tolerated, was indicative of efficient inhaled alveolar deposition, and delivered oral-superior lung levels with reduced systemic exposure. These results further provided dose-selection guidance for the completed Phase 1a trial.

Avalyn will also review the results from the Phase 1b trial of AP01 (ATLAS) in participants with idiopathic pulmonary fibrosis (IPF). As previously published, participants in the 100 mg arm of the trial experienced forced vital capacity (FVC) stabilization on average, which correlated with changes in quantitative lung fibrosis scores measured by high-resolution computed tomography (HRCT) imaging. The HRCT response was strongly associated with the King’s Brief Interstitial Lung Disease (KBILD) questionnaire, a validated and meaningful quality of life endpoint for patients living with ILD.

An additional Avalyn poster will highlight the safety, tolerability, and efficacy findings from the open-label extension (OLE) following the ATLAS trial. The OLE enrolled ATLAS participants and AP01-naïve pulmonary fibrosis participants, and the data showed a durable and consistent response to AP01, including fewer reported adverse events compared to historical reports of oral pirfenidone.

PFF Summit Presentations and Details:

Title: Inhaled Nintedanib: Predictive Sheep Model for Human Dose Selection and Tolerability

Title: Improvement in HRCT Lung Fibrosis with Inhaled Pirfenidone Is Associated with Better Health-Related Quality of Life Scores in Patients with Idiopathic Pulmonary Fibrosis

Title: Long-term Safety Data of Inhaled Pirfenidone (AP01) in Idiopathic Pulmonary Fibrosis (IPF) and Non-IPF Interstitial Lung Disease (ILD) Patients

The three posters will be presented today, November 9, 2023, from 5:00 – 8:00 p.m. ET, and copies of each are available on the Avalyn website.

Avalyn will also be present throughout the Summit at booth #204.

About Avalyn Pharma

Avalyn is a biopharmaceutical company developing targeted therapeutics for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication to the site of disease. Avalyn’s pipeline is led by AP01, an optimized inhaled formulation of pirfenidone, which has been assessed in 150 individuals with different forms of pulmonary fibrosis and demonstrated clinical proof-of-concept with improved efficacy and safety over existing therapies. For more information, please visit


Alex Straus
THRUST Strategic Communications

Cara Mayfield
THRUST Strategic Communications