Savara presented data at the 2022 European Respiratory Society (ERS) International Congress

AUSTIN, Texas–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, presented three posters at the 2022 ERS International Congress held September 4-6e in Barcelona, ​​Spain.

Below are summaries of each poster presented:

Abstract #2170: “IMPALA: Measures of Efficacy in Patients with Autoimmune Alveolar Pulmonary Proteinosis (aPAP) Who Required Whole Lung Lavage” presented by Y. Inoue, MD, Ph.D.

  • Presenting data from a post hoc analysis of the IMPALA clinical trial evaluating the benefit of continuous daily administration of 300 μg inhaled molgramostim versus placebo in patients with aPAP who required complete lung lavage ( WLL) during the double-blind treatment period. A total of 10 patients experienced WLL during the treatment period (molgramostim: n=4, placebo: n=6)

  • The data demonstrated that patients treated with molgramostim after undergoing WLL showed greater improvements in measurements of gas exchange parameters, including the alveolar-arterial oxygen difference (A-aDO2) and the diffusing capacity of the lungs for carbon monoxide (DLco) corrected for the hemoglobin level. Additionally, patients reported improved health status, as measured by the St. George’s Respiratory Questionnaire -Total and -Activity, compared to placebo-treated patients.

  • Click here to see the poster

Abstract #1154: “Safety and Tolerability of Inhaled Molgramostim in Autoimmune Alveolar Pulmonary Proteinosis (aPAP)” presented by F. Bonella, MD, Ph.D.

  • Includes safety data from an open-label, uncontrolled extension study of IMPALA (IMPALA-X) in which 60 patients received treatment with inhaled molgramostim 300 μg/day administered intermittently (1 week walking and 1 week rest). This study was terminated prematurely because the IMPALA results did not support this dosing regimen.

  • In IMPALA-X, no new safety signals were observed and the most common treatment-related adverse events after 93.4 patient-years of exposure were mild to moderate cough, nasopharyngitis and infection of the respiratory tracts.

  • Click here to see the poster

Abstract #3136: “IMPALA-2: Choice of DLco as the primary endpoint in autoimmune pulmonary alveolar proteinosis (aPAP)” presented by B. Trapnell, MD

  • Described rationale for using DLco as the primary endpoint in the IMPALA-2 clinical trial, including:

    • In the first IMPALA trial, DLco showed robust improvements in patients with aPAP who were treated with 300 μg continuous daily molgramostim compared to those treated with placebo

    • DLco is a standardized and widely used pulmonary function test directly related to the pathophysiology of aPAP, and predictive of the major clinical event of WLL

  • IMPALA-2 is an ongoing pivotal global Phase 3, randomized, double-blind, placebo-controlled clinical trial evaluating molgramostim 300 μg once daily in patients with aPAP

  • Click here to see the poster

The full content of these posters is available in the Congress online program and on the Articles and Publications page of the Savara corporate website. In addition, the posters should be published in a supplement to the European Respiratory Journalsl (ERJ) by the end of November 2022. For more details on the ERS International Congress, please visit https://www.ersnet.org/congress-and-events/congress/.

About aPAP

Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare lung disease that belongs to a family of distinct rare lung diseases collectively known as pulmonary alveolar proteinosis (PAP). aPAP accounts for approximately 90% of all patients with PAP. Although aPAP can affect people of any age, race, or gender, its onset most often occurs in people between the ages of 30 and 40. PAP is characterized by the accumulation of surfactant in the alveoli, or air sacs, of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the inside of the alveoli to prevent the lungs from collapsing. The root cause of aPAP is an autoimmune response against GM-CSF, a naturally occurring protein in the body. Lung macrophages must be stimulated by GM-CSF to function properly, but in aPAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to perform their tasks, including including removal of surfactant from the alveoli. In aPAP, the feeling of having difficulty breathing is the most common symptom. People with aPAP may also experience chronic cough, fatigue, sputum production, reduced ability to exercise, and bouts of fever due to underlying lung infections. There are currently no approved pharmaceutical treatment options for aPAP.

About Savara

Savara is a clinical-stage biopharmaceutical company specializing in rare respiratory diseases. Our flagship program, molgramostim nebulizer solution, is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim is administered via an experimental eFlow® nebulizer system (PARI Pharma GmbH). Our leadership team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs and effectively advancing product candidates through approval and commercialization. More information can be found at www.savarapharma.com. (Twitter: @SavaraPharmaLinkedIn: www.linkedin.com/company/savara-pharmaceuticals/).



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