Savara Announces Encore Presentations of Results From the Phase 3 IMPALA-2 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at CHEST 2025
-- Savara's Partner, TrilliumBiO, to Present Encore Data on the Development of a Dried Blood Spot Test to Aid in the Diagnosis of aPAP --
Savara Inc. (NASDAQ:SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced the acceptance of two abstracts for poster presentation and one abstract as an oral presentation at CHEST 2025 in Chicago, Illinois, October 19-22. The Company will also host a Learning Theatre titled "Advances in Autoimmune Pulmonary Alveolar Proteinosis" at the meeting which is open to all registered conference attendees.
CHEST 2025 Posters, Oral Session and Learning Theater
Savara Presentations
Oral Presentation Title: Efficacy of Inhaled Molgramostim According to Severity of Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Session Title: Innovations in Assessment and Treatment of Fibrosing Lung Disease
Session ID: 4053
Date/Time of Presentation Session: October 21, 2025, 10:56-11:00 AM CDT
Location: Exhibit Hall Rapid Fire 3A, McCormick Place, Chicago
Presenter: Cormac McCarthy, M.D., Ph.D., FRCPI, Associate Professor of Medicine at the University College Dublin (UCD) and Consultant Respiratory Physician at St. Vincent's University Hospital, Dublin, Ireland
Poster Title: Relationship Between Pulmonary Gas Transfer, Respiratory Health-Related Quality of Life (HRQoL), Exercise Capacity, and Surfactant Burden in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Session Title: Diffuse Lung Disease Scientific Abstract Posters (D)
Date/Time of Poster Discussion Session: October 22, 2025, 10:20-11:05 AM CDT
Poster Number: 4260
Location: Poster Hall Exhibit, McCormick Place, Chicago
Presenter: Bruce Trapnell, M.D., Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine
TrilliumBiO Presentation
Poster Title: Development of a Dried Serum Assay for the Detection of GM-CSF Antibodies to Aid in the Diagnosis of Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Session Title: Diffuse Lung Disease Scientific Abstract Posters (D)
Poster Number: 4257
Date/Time of Poster Presentation Session: October 22, 2025, 10:20-11:05 AM CDT
Location: Poster Hall Exhibit, McCormick Place, Chicago
Presenter: Eagappanath Thiruppathi, Ph.D., Director, Test and Method Development, TrilliumBiO
Savara Learning Theater
Title: Advances in Autoimmune Pulmonary Alveolar Proteinosis
Description: Kevin Davidson, M.D., FCCP, will provide an update on autoimmune pulmonary alveolar proteinosis, including the pathophysiology of this rare lung disease, signs and symptoms, diagnosis and management, and burden of illness.
Date/Time: October 21, 12:30-1:15 pm CDT
Location: Learning Theatre 1, McCormick Place, Chicago
Presenter: Kevin Davidson, M.D., FCCP, Director of Interventional Pulmonology and Critical Care Medicine, WakeMed Hospitals, Raleigh, NC, USA
Following the sessions, the posters and presentation slides will be available on the Congresses & Publications page of the Company's corporate website.
IMPALA-2 is a global, pivotal, Phase 3, 48-week, randomized, double-blind, placebo-controlled clinical trial designed to compare the efficacy and safety of molgramostim 300 mcg self-administered once daily by inhalation with matching placebo in patients with aPAP. The trial is being conducted at 43 clinical trial sites across 16 countries, including the U.S., Canada, Japan, South Korea, Australia, and countries in Europe, including Turkey. The primary efficacy assessment was diffusing capacity of the lungs for carbon monoxide (DLco%), a gas transfer measure, and the primary endpoint was change from baseline to Week 24 in percent predicted DLco%, with a secondary endpoint of change from baseline to Week 48 in percent predicted DLco%. Three additional secondary efficacy variables evaluated clinical measures of direct patient benefit: St. George's Respiratory Questionnaire (SGRQ) Total score, SGRQ Activity score, and exercise capacity using a treadmill test, with each endpoint measured at Weeks 24 and 48. The primary time point for efficacy assessments was at Week 24; however, efficacy was assessed through Week 48 to evaluate durability of effect. Safety was assessed through Week 48. All patients who completed the 48-week double-blind treatment period continued into a 96-week open-label period during which molgramostim 300 mcg is administered once daily.
About Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in aPAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution (molgramostim), is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is delivered via a proprietary investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of molgramostim. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.
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Media and Investor Relations Contact
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
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