Savara Inc. (Nasdaq: SVRA), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, announced plans to present new data from its pivotal Phase 3 IMPALA-2 clinical trial of molgramostim inhalation solution for autoimmune pulmonary alveolar proteinosis (aPAP) at multiple international medical conferences in 2025.
The company will showcase the trial results at the American Thoracic Society (ATS) International Conference in San Francisco (May 16-21, 2025), the 65th Congress of the German Society of Pneumology in Leipzig (April 9-12, 2025), and the 65th Annual Meeting of the Japanese Respiratory Society in Tokyo (April 11-13, 2025).
Key Findings to Be Presented at ATS 2025
Two abstracts have been accepted for poster presentation at the ATS International Conference, highlighting significant clinical benefits of molgramostim in aPAP patients:
The first poster, "Molgramostim Reduces Surfactant Burden and Number of Whole Lung Lavage Procedures in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results From the IMPALA-2 Phase 3 Clinical Trial," will be presented by Dr. Tisha S. Wang, Professor of Clinical Medicine at the University of California Los Angeles. This presentation will take place on Sunday, May 18, 2025, from 9:15 to 11:15 AM PT.
The second poster, "The Effects of Molgramostim on Respiratory Health-related Quality of Life and Patient-reported Outcomes in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP)," will be presented by Dr. Ali Ataya, Associate Professor of Medicine at the University of Florida, Division of Pulmonary and Critical Care Medicine. This presentation is scheduled for Sunday, May 18, 2025, from 11:30 AM to 1:15 PM PT.
Both abstracts will be published in a supplement of the American Journal of Respiratory and Critical Care Medicine on May 1, 2025, and will subsequently be available on Savara's corporate website.
Industry Theater on aPAP Advances
In addition to the poster presentations, Savara will host an Industry Theater titled "Advances in Autoimmune Pulmonary Alveolar Proteinosis" at the ATS conference. The session will feature two world-renowned experts in the field:
- Dr. Bruce Trapnell, a leading researcher in aPAP
- Dr. Cormac McCarthy, a clinical expert in rare lung diseases
The experts will provide comprehensive updates on aPAP, including its pathophysiology, clinical manifestations, disease burden, and current approaches to diagnosis and management. The Industry Theater will take place on Tuesday, May 20, 2025, from 1:00 to 2:00 PM PT at the Innovation Theater 3 in the Moscone Center Exhibit Hall.
Understanding aPAP: A Rare Lung Disease with Significant Burden
Autoimmune pulmonary alveolar proteinosis is a rare lung disease characterized by the abnormal accumulation of surfactant in the alveoli. In healthy individuals, alveolar macrophages stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) clear excess surfactant. However, in aPAP patients, antibodies neutralize GM-CSF, preventing macrophages from properly clearing surfactant.
This surfactant buildup leads to impaired gas exchange, resulting in symptoms such as shortness of breath, cough, and fatigue. Patients may also experience fever, chest pain, or hemoptysis, particularly if secondary lung infections develop. Long-term complications can include lung fibrosis and, in severe cases, the need for lung transplantation.
The current standard of care for aPAP is whole lung lavage, an invasive procedure that requires general anesthesia and mechanical ventilation. This highlights the significant unmet need for effective pharmacological treatments.
Molgramostim: A Potential Breakthrough Therapy
Molgramostim is a recombinant human GM-CSF delivered via an investigational eFlow® Nebulizer System specifically developed for inhalation of large molecules. By replacing the neutralized GM-CSF, molgramostim aims to restore normal macrophage function and surfactant clearance in aPAP patients.
The IMPALA-2 trial is a pivotal Phase 3 study evaluating the efficacy and safety of molgramostim in aPAP patients. The top-line data to be presented at these international conferences represent a significant milestone in the development of this potential first-in-class therapy for a disease with limited treatment options.
About Savara Inc.
Savara is a clinical-stage biopharmaceutical company focused on developing treatments for rare respiratory diseases. The company's management team brings extensive experience in rare respiratory conditions, pulmonary medicine, and drug development.
The presentations at these prestigious international conferences underscore the global significance of the IMPALA-2 trial results and Savara's commitment to advancing innovative therapies for patients with rare respiratory diseases like aPAP.
