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Savara Announces New Data from Pivotal Phase 3 IMPALA-2 Trial of Molgramostim Nebulizer Solution (Molgramostim) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Were Presented at the European Respiratory Society (ERS) Congress 2024
Savara Inc. (Nasdaq: SVRA) presented new data from the Phase 3 IMPALA-2 trial of molgramostim for autoimmune Pulmonary Alveolar Proteinosis (aPAP)at the ERS Congress 2024. The trial met its primary endpoint, showing significant improvement in DLCO% at Week 24, sustained through Week 48. New results demonstrated:
1. Significant improvement in Disease Severity Score at Weeks 24 and 48
2. Higher proportions of DLCO% responders compared to placebo
3. Improved SGRQ Total Score responder analysis results
4. Significant improvement in Ground Glass Opacification Score at Week 24
Molgramostim was well-tolerated with a favorable benefit/risk profile. Savara plans to complete the BLA submission in the first half of 2025.
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