Avalyn Pharma’s Inhaled Pulmonary Fibrosis Programs to be Highlighted at Upcoming ERS International Congress

Interstitial Lung Disease Experts Present Forced Vital Capacity Results from ATLAS Study

Seattle, Sept. 07, 2023 (GLOBE NEWSWIRE) — Avalyn Pharma Inc., a clinical-stage biopharmaceutical company focused on development of targeted therapies for life-threatening pulmonary diseases, announced that Dr. Nazia Chaudhuri will be presenting data from Avalyn’s Phase 1b ATLAS study showing the positive impact of AP01 (inhaled pirfenidone) on the forced vital capacity (FVC) of adults with idiopathic pulmonary fibrosis compared to historical controls. These findings will be presented in a late-breaking poster at the European Respiratory Society’s International Congress in Milan, Italy. Dr. Chaudhuri is a consultant in respiratory medicine at the Ulster University School of Medicine in Ireland and was an investigator in the ATLAS study. A copy of the poster will be made available on the Avalyn website in accordance with the society’s embargo policy. 

In addition, Dr. Alex West, the interstitial lung disease lead at Guy’s and St Thomas’ Hospital, London and an investigator in the ATLAS study will be reviewing FVC results from the two patient populations enrolled in the ATLAS study and the subsequent open-label extension study: idiopathic pulmonary fibrosis (IPF) patients and progressive pulmonary fibrosis (PPF) patients during poster and podium presentations.

Presentation Details:

Poster Title: Nebulised Pirfenidone in Non-Idiopathic Pulmonary Fibrosis (IPF) Progressive Pulmonary Fibrosis (PPF): First Look at FVC Data
Location: PA405 in session 58
Day/Time: September 10, 8:00 – 9:30 a.m.

Presentation Title: Nebulised Pirfenidone in Idiopathic Pulmonary Fibrosis (IPF): First Look at FVC Data
Location: OA2581 in session 267
Day/Time: September 11, 11:00 a.m. – 12:15 p.m. 

Poster Title: Inhaled Pirfenidone (AP01) Forced Vital Capacity (FVC) Data from the ATLAS Study vs Placebo from 3 Historical Idiopathic Pulmonary Fibrosis (IPF) Randomised Controlled Trials
Location: PA3485 in session 349
Day/Time: September 11, 4:00 – 5:30 p.m.

About the ATLAS Study

The open-label ATLAS study enrolled 91 adults with IPF who were intolerant of or ineligible for oral pirfenidone or nintedanib. The ATLAS study assessed the safety, tolerability, and efficacy of two AP01 doses (50 mg QD or 100 mg BID) in patients with IPF. Of the 91 participants who enrolled, 77 (85%) completed 24 weeks of treatment. Following review of week 24 data, the data safety monitoring board (DSMB) recommended all participants transition to the higher dose of AP01. Dosing continued in the ATLAS study through week 72, after which all participants were eligible to participate in the AP01-005 open-label extension study. 

Of the 55 participants who reached week 72, 41 (75%) continued into the open-label extension. An additional 59 adults with either IPF or PPF were recruited to participate in AP01-005. To date, 100 individuals have enrolled in the open-label extension, 17 of whom have been on study medication for over three years.

About Avalyn Pharma

Avalyn is a biopharmaceutical company developing targeted therapeutics for the treatment of rare respiratory diseases including idiopathic pulmonary fibrosis (IPF) and other interstitial lung diseases (ILD). ILDs are characterized by scarring, decline in lung function, reduced exercise capacity and quality of life, and are associated with increased mortality. Currently approved therapeutic options slow ILD progression but are associated with significant toxicities, which restrict their use and dosing. Avalyn is developing a pipeline of inhaled therapeutics designed to reduce systemic exposure and deliver medication to the site of disease. AP01, Avalyn’s lead candidate, is an inhaled formulation of pirfenidone optimized for delivery via inhalation. In a recent clinical study of two doses assessed in 91 individuals with IPF, AP01 demonstrated the potential to improve both efficacy and safety over existing therapy. More information can be found at www.avalynpharma.com.

CONTACT: General Inquiries: 
Marc Schneebaum 
Chief Financial Officer, Avalyn Pharma Inc

Aline Sherwood
Scienta Communications

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