Avalyn Pharma to present AP01 usability and IPF patient data at ATS 2026
Avalyn Pharma is set to present two poster sessions at the American Thoracic Society 2026 International Conference, running 15–20 May in Orlando, Florida, with findings drawn from patient and clinician experience research around its inhaled pirfenidone programme, AP01.
The first presentation, led by Stephen Pham, Senior Vice President of Product Development, reports on a formative usability study of the eFlow® Nebuliser System — the drug-device combination being developed to deliver AP01 directly to the lungs. The study gathered structured feedback from patients, care partners, and clinicians to iterate on instructional materials, a process Avalyn describes as central to its development philosophy. The second poster, fronted by Dolly Kervitsky of patient advocacy body PF Warriors, examines what people living with idiopathic pulmonary fibrosis (IPF) consider a genuinely supportive healthcare experience, highlighting timely clinical communication, inclusion of care partners, and the value of disease-specialist expertise.
Both posters sit within Thematic Poster Session B39 — Breath and Burden: Diffuse Lung Diseases and Daily Life — scheduled for Monday 18 May.
Context for AP01 and Avalyn's pipeline
AP01 is an inhaled reformulation of pirfenidone, an established antifibrotic approved in both the US and Europe as an oral agent for IPF. Avalyn's rationale is that lung-targeted delivery could preserve or improve clinical activity while reducing the systemic side-effect burden — principally photosensitivity and gastrointestinal toxicity — that limits tolerability of oral pirfenidone in practice. The programme is currently being evaluated in MIST, a global Phase 2b trial in progressive pulmonary fibrosis. A second programme, AP02 (inhaled nintedanib), is in a separate Phase 2 trial, AURA-IPF, and a fixed-dose inhaled combination of both agents, AP03, is also in early development.
Craig Conoscenti, Avalyn's Senior Vice President of Clinical Development, will co-chair the Respiratory Innovation Summit on 15–16 May, giving the company additional visibility at the conference beyond its poster slots.
Market and competitive landscape
Pulmonary fibrosis is a small but commercially significant rare-disease area. Both pirfenidone (Roche/Genentech) and nintedanib (Boehringer Ingelheim) are large-molecule oral franchises with established market positions; Avalyn's inhaled reformulation strategy is effectively a life-cycle management play on validated mechanisms, which carries a lower de-risking bar than first-in-class development but faces the challenge of demonstrating a clinically meaningful tolerability or efficacy advantage over the originator formulations. Several academic groups and smaller biotechs are also exploring inhaled antifibrotic approaches, though no inhaled pirfenidone or nintedanib product has yet reached regulatory approval.
The patient-centred research being presented at ATS — usability data and qualitative experience surveys — is unlikely to move the clinical dial on its own, but it signals Avalyn's intent to build a regulatory and commercial narrative around real-world usability ahead of pivotal data from MIST and AURA-IPF. Full Phase 2b readouts from both trials will be the next key inflection points for the company.
Abstracts for both presentations have been accepted to the online programme of the American Journal of Respiratory and Critical Care Medicine, scheduled for publication in May 2026.