MedPath

Savara's Molgramostim Shows Promise in Autoimmune Pulmonary Alveolar Proteinosis

• Savara Inc. announced an encore presentation of Phase 3 IMPALA-2 trial results for Molgramostim at the British Thoracic Society Winter Meeting 2024. • The IMPALA-2 trial demonstrated that inhaled Molgramostim improves pulmonary gas exchange in patients with autoimmune Pulmonary Alveolar Proteinosis (aPAP). • Dr. Cormac McCarthy presented data showing Molgramostim also enhances respiratory health-related quality of life in aPAP patients. • The presentation slides will be available on Savara's corporate website following the session on November 29, 2024.

Savara Inc. (Nasdaq: SVRA) presented results from its Phase 3 IMPALA-2 trial of molgramostim inhalation solution for autoimmune pulmonary alveolar proteinosis (aPAP) at the British Thoracic Society (BTS) Winter Meeting in London. The data, presented by Dr. Cormac McCarthy on November 29, 2024, highlight molgramostim's potential to improve pulmonary gas exchange and respiratory health-related quality of life in aPAP patients.

IMPALA-2 Trial Results

The IMPALA-2 trial evaluated the efficacy and safety of inhaled molgramostim in patients with aPAP, a rare lung disease characterized by surfactant accumulation in the alveoli. The study met its primary endpoints, demonstrating statistically significant improvements in pulmonary gas exchange and key secondary endpoints related to respiratory function and quality of life.

Mechanism of Action and Clinical Significance

Molgramostim is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). In aPAP, antibodies neutralize GM-CSF, impairing alveolar macrophage function and surfactant clearance. Molgramostim aims to restore macrophage function, facilitating surfactant clearance and improving gas exchange. The clinical significance lies in addressing the unmet need for effective therapies in aPAP, where current treatment options are limited and can be invasive.

Presentation Details

Dr. McCarthy's presentation, titled "Inhaled Molgramostim Improves Pulmonary Gas Exchange and Respiratory Health-Related Quality of Life in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from IMPALA-2," took place during the "The Famous Five" session at the BTS Winter Meeting. The presentation slides are available on the Articles & Publications page of Savara's corporate website.

About aPAP

Autoimmune PAP is a rare condition where surfactant builds up in the lung's air sacs, impairing gas exchange and causing shortness of breath, cough, and fatigue. Long-term complications include lung fibrosis and the potential need for lung transplantation. Savara is focused on addressing this unmet medical need with molgramostim.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Novartis' Intrathecal Zolgensma Shows Positive Phase III Results for SMA Type 2

Novartis' intrathecal onasemnogene abeparvovec (OAV101 IT) met its primary endpoint in the Phase III STEER study for SMA Type 2.
The STEER trial demonstrated a statistically significant increase in motor function, as measured by HFMSE scores, in treatment-naïve patients.

Savara Initiates FDA Submission for MOLBREEVI in Rare Lung Disease

Savara Inc. has begun a rolling submission of a Biologics License Application (BLA) to the FDA for MOLBREEVI, a treatment for autoimmune pulmonary alveolar proteinosis (aPAP).
MOLBREEVI has received Fast Track, Breakthrough Therapy, and Orphan Drug Designations, potentially expediting its review and approval process.

MaaT Pharma's MaaT013 Shows Promising Data in Acute Graft-versus-Host Disease

MaaT Pharma presented updated data on MaaT013, showcasing sustained high response rates in patients with acute Graft-versus-Host Disease (aGvHD) from its Early Access Program.
The data revealed a gastrointestinal overall response rate of 51% at Day 28 and an overall response rate of 49% across all organs in the treated patients.

Savara's Molgramostim Shows Promise in Autoimmune Pulmonary Alveolar Proteinosis

Savara Inc. presented results from the Phase 3 IMPALA-2 trial of molgramostim inhalation solution for autoimmune pulmonary alveolar proteinosis (aPAP).
The presentation highlighted molgramostim's ability to improve pulmonary gas exchange and respiratory health-related quality of life in aPAP patients.

Savara Announces Presentation of Phase 3 IMPALA-2 Trial Results for Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis

Savara Inc. will present results from the Phase 3 IMPALA-2 trial of inhaled molgramostim at the British Thoracic Society Winter Meeting.
The presentation will highlight molgramostim's impact on improving pulmonary gas exchange and respiratory health-related quality of life in aPAP patients.

MaaT Pharma's MaaT013 Shows Promising Long-Term Efficacy in Refractory GI-aGvHD

MaaT Pharma's MaaT013 demonstrates a 51% gastrointestinal overall response rate (GI-ORR) at day 28 in steroid-refractory or dependent gastrointestinal acute Graft-versus-Host Disease (GI-aGvHD) patients.
Long-term follow-up data reveals a 42% overall survival rate at 24 months, with significantly higher survival in patients responding to MaaT013 compared to non-responders.

HUTCHMED's Sovleplenib Shows Promising Long-Term Efficacy in ITP Phase III Trial

HUTCHMED will present updated data from the ESLIM-01 Phase III trial of sovleplenib in adult patients with primary immune thrombocytopenia (ITP) at the ASH Annual Meeting.
Long-term data from the open-label sub-study of ESLIM-01 demonstrated effective and sustained platelet count increase with sovleplenib in chronic ITP patients in China.

Airsupra Demonstrates Significant Reduction in Asthma Exacerbations in Phase 3 BATURA Trial

The Phase 3b BATURA trial of Airsupra (albuterol/budesonide) showed a statistically significant reduction in severe asthma exacerbations compared to albuterol alone.
The trial was halted early due to the "overwhelming" efficacy of Airsupra, as determined by the independent data monitoring committee.

Molgramostim Shows Sustained Benefits in Phase 3 Trial for Autoimmune Pulmonary Alveolar Proteinosis

Molgramostim demonstrated a statistically significant improvement in lung diffusing capacity (DLCO%) at Week 24, which was sustained through Week 48 in aPAP patients.
The IMPALA-2 trial showed molgramostim significantly improved disease severity scores and ground glass opacification, indicative of reduced surfactant burden.

Abivax's Phase 3 ABTECT Trial for Ulcerative Colitis Reaches Enrollment Milestone

Abivax's Phase 3 ABTECT trial, evaluating obefazimod for ulcerative colitis, has surpassed 600 patients enrolled, marking a significant milestone.
The trial is on track to achieve full enrollment in early Q1 2025, reinforcing the company's timeline for this pivotal study.

Reference News

[1]
Savara to Present Phase 3 Trial Results for Breakthrough aPAP Treatment at BTS Meeting
stocktitan.net · Nov 22, 2024

Savara announces encore presentation of Phase 3 IMPALA-2 trial results for Molgramostim inhalation solution in aPAP pati...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy