Avalyn Pharma Showcasing Therapeutic Approach and Clinical Status at ATS 2023 and the Respiratory Innovation Summit (RIS)

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– Avalyn CEO to Present in Company Showcase and Moderate Panel Discussion at ATS RIS –

– Results from Long-Term Treatment of Pulmonary Fibrosis with AP01 to be Presented at ATS –

May 11, 2023 – SEATTLE — Avalyn Pharma Inc., a clinical-stage biopharmaceutical company developing inhaled therapies to treat life-threatening pulmonary diseases, today announced that the company will be participating in the upcoming American Thoracic Society (ATS) annual meeting and its associated Respiratory Innovation Summit (RIS), which are being held at the Marriott Marquis in Washington, DC. During RIS, Lyn Baranowski, Avalyn’s CEO, will moderate a discussion among a panel of experts from the ATS Public Advisory Roundtable (PAR), a public-private partnership designed to advance educational, research, patient care, and advocacy goals; and will separately present a corporate overview about Avalyn during the RIS company showcase. In addition, Felix Woodhead, MD PhD, senior medical director at Avalyn, is presenting long-term tolerability data from the AP01-005 open-label extension (OLE) trial during ATS, which is taking place from May 19- 24, 2023.

AP01-005 enrolled individuals with idiopathic pulmonary fibrosis (IPF) who had completed the Phase 1b ATLAS study of AP01 (inhaled pirfenidone), plus two new AP01 naïve cohorts: patients with IPF or non-IPF interstitial lung disease  (i.e., progressive pulmonary fibrosis (PPF)) who were intolerant of or ineligible for oral antifibrotic medication. All participants self-administered 100 mg AP01 twice-daily. Data presented at ATS will include safety and tolerability findings at Week 48 for the AP01-naive IPF and PPF patients recruited into the OLE. Additionally, the presentation will include long-term efficacy data on patients who continued into the OLE study from the ATLAS study, some of whom have been on therapy for more than 3 years.

Presentation Details:

Title: Patient Group Leaders from the ATS Public Advisory Roundtable
Moderator: Lyn Baranowski
Program: Respiratory Innovation Summit
Time: May 19, 2023 at 6:40pm ET
Title: Corporate Presentation: Targeted Therapeutics for Life-Threatening Pulmonary Diseases
Presenter: Lyn Baranowski
Time: May 20, 2023 at 3:45pm ET
Program: Respiratory Innovation Summit
Session: Fibrosis Innovators
Title: Long-term Safety Data of Inhaled Pirfenidone (AP01) in Idiopathic Pulmonary Fibrosis (IPF) and Non-IPF Interstitial Lung Disease (ILD) Patients
Presenter: Dr. Felix A. Woodhead
Program: American Thoracic Society Annual Meeting
Time: May 22, 2023 at 9:24 AM ET
Session: B17 – Emerging Data on Disease and Symptom-Based Therapeutics for Patients with IPF

About AP01 (Pirfenidone Solution for Inhalation)

Pirfenidone is a small molecule shown to inhibit fibroblast differentiation and extracellular matrix (ECM) production. AP01 is an inhaled aerosol formulation of pirfenidone that is delivered using an optimized eFlow® Technology Nebulizer, a high efficiency vibrating membrane nebulizer similar in design and operation to PARI’s 510(k) cleared/FDA-approved eFlow-based nebulizers marketed with other products for other disease indications. This administration method allows a smaller pirfenidone dose to be delivered as a soft mist directly to the lung, maximizing pirfenidone’s effect on diseased lung tissue while sparing tissue outside of the lungs from the debilitating toxicities associated with oral delivery. Avalyn is planning to advance AP01 (100 mg BID) into the next phase of the clinical program in 2023.

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