Publications

Avalyn is developing inhaled formulations of approved medications for rare respiratory diseases. Our initial focus is on treating Interstitial Lung Diseases (ILD), including Pulmonary Fibrosis and rare diseases that dramatically impact patient quality of life.

AP01

October 22, 2024

Inhalation Innovation: Phase IIb Study Design of Inhaled Pirfenidone in the Treatment of Progressive Pulmonary Fibrosis

Martin Kolb, Colin Reisner, Deepthi Nair, Felix Woodhead, Howard Lazarus, Craig Conoscenti

September 8, 2024

Correlation of Early Cough with Disease Activity measured by High-resolution CT in ATLAS: a Phase 1b Study of Inhaled Pirfenidone in Idiopathic Pulmonary Fibrosis

Grace Kim, Jonathan Goldin, Felix A. Woodhead, Deepthi K. Nair, Howard M. Lazarus, Craig Conoscenti

September 8, 2024

Cough adverse events and FVC decline in the ATLAS study of inhaled pirfenidone (AP01) in Idiopathic Pulmonary Fibrosis

Nazia Chaudhuri, Barnaby Hirons, Felix A. Woodhead, Allison Trucillo, Hao Bao, Deepthi K. Nair, Colin Reisner, Andrey Pavlov, Craig Conoscenti, Howard M. Lazarus, Surinder Birring

September 8, 2024

Inhalation Innovation: Phase 2b Study Design on Inhaled Pirfenidone in the Treatment of Progressive Pulmonary Fibrosis

Martin Kolb, Colin Reisner, Deepthi K. Nair, Felix A. Woodhead, Howard M. Lazarus, Craig Conoscenti

May 20, 2024

Safety and efficacy of inhaled pirfenidone (AP01) in the ATLAS open-label extension study

 Margaret L. Wilsher, Felix A. Woodhead, Deepthi K. Nair, Hao Bao, Howard M. Lazarus, Tamera J. Corte

May 20, 2024

Inhaled pirfenidone reduces the risk of disease progression: a post-hoc analysis of the ATLAS study

Lancaster LH, Lazarus HM, Woodhead FA, Nair DK, Pavlov A, Reisner C, Nathan SD

November 13, 2023

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

Woodhead FA, Nair D, Bao H, et al. (2023) Poster presented at Pulmonary Fibrosis Foundation (PFF) Summit

November 13, 2023

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

Woodhead FA, Kim GHJ, Goldin JG, et al. (2023) Poster presented at Pulmonary Fibrosis Foundation (PFF) Summit

September 12, 2023

Inhaled pirfenidone (AP01) forced vital capacity (FVC) data from the ATLAS study vs placebo from 3 historical idiopathic pulmonary fibrosis (IPF) randomised controlled trials (RCTs)

Chaudhuri N, Lancaster L, Palmer S, et al. (2023) poster presented at European Respiratory Society (ERS) International Congress

September 12, 2023

Nebulised Pirfenidone in Non-Idiopathic Pulmonary Fibrosis (IPF) Progressive Pulmonary Fibrosis (PPF): First Look at FVC Data

West A, Lawrence A, Bao H, et al (2023) poster presented at European Respiratory Society (ERS) International Congress

May 23, 2023

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

Woodhead FA, Nair D, Bao H, et al. (2023) ePoster presented at American Thoracic Society (ATS) International Conference

March 23, 2023

Inhaled pirfenidone solution (AP01) for IPF: a randomised, open-label, dose–response trial

West A, Chaudhuri N, Barczyk A, et al. (2023) Thorax 

December 12, 2022

Inhaled Pirfenidone Is Associated With Better Quality of Life Scores in Idiopathic Pulmonary Fibrosis

Kim G, Goldin J, Woodhead F, et al. (2022) European Respiratory Journal

February 6, 2020

Improvement in HRCT Lung Fibrosis With Inhaled Pirfenidone Is Associated With Better Health-Related Quality of Life Scores in Patients With IPF

Woodhead FA, Kim GHJ, Goldin JG, et al. (2022) poster presented at the European Respiratory Society (ERS) International Congress

January 4, 2020

A Randomized Double-Blind Placebo-Controlled Dose-Escalation Phase 1 Study of Aerosolized Pirfenidone

Khoo JK, Montgomery AB, Otto KL, et al. (2018) Journal of Aerosol Medicine and Pulmonary Drug Delivery

December 12, 2019

Aerosol Pirfenidone Pharmacokinetics after Inhaled Delivery in Sheep: a Viable Approach to Treating Idiopathic Pulmonary Fibrosis

Kaminskas LK, Landersdorfer CB, Bischof RJ, et al. (2020) Pharmaceutical Research

February 6, 2018

Pharmacokinetics and Safety of Pirfenidone Following Inhaled Delivery to Sheep: A Viable Approach to Treating Idiopathic Pulmonary Fibrosis

Surber M, Kaminskas L, Landersdorfer C, et al. (2019) poster presented at American Thoracic Society (ATS) International Conference

January 10, 2014

Inhalation Improves Pirfenidone Animal Efficacy Through Superior Pulmonary and Vascular Pharmacokinetics

Surber MW, Poulin D, McInally K, et al. (2014) poster presented at American Thoracic Society (ATS) International Conference

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AP02

November 13, 2023

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

Surber MW, Pham S, Bischof R. (2023) Poster presented at Pulmonary Fibrosis Foundation (PFF) Summit

September 12, 2023

Nebulised Pirfenidone in Idiopathic Pulmonary Fibrosis (IPF): First Look at FVC Data

West A, Lawrence A, Bao H, et al. (2023) oral presentation given at European Respiratory Society (ERS) International Congress

March 24, 2021

Hypoxia Inducible Factor 1A Supports a Pro-Fibrotic Phenotype Loop in Idiopathic Pulmonary Fibrosis

Shochet GE, Bardenstein-Wald B, McElroy M, et al (2021). International Journal of Molecular Science

August 1, 2020

Inhalation: A Means to Explore and Optimize Nintedanib’s Pharmacokinetic/codynamic Relationship

Shochet GE, Pham S, Beck S, et al. (2020) Pulmonary Pharmacology

January 30, 2020

Direct Lung Administration of Nintedanib Reduces Lung Fibrosis in a Multi-Challenge Bleomycin Rat Model

McElroy MC, Beck S, Baily J, et al. (2020) poster presented at American Thoracic Society (ATS) International Conference

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Devices

February 6, 2022

Inhalation: A Means to Improve Existing IPF Therapies

Surber MW, Montgomery AB, Otto K, et al. (2022)

February 6, 2015

Assessment of Regional Lung Deposition of Aerosol Aerodone in IPF Patients Using Functional Respiratory Imaging

Vos W, Van Holsbeke C, Ferreira F, et al. (2015) poster presented at Pulmonary Fibrosis Foundation Summit: From Bench to Bedside

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