Savara Inc. announced that the results from its pivotal Phase 3 IMPALA-2 clinical trial will be published online in the New England Journal of Medicine (NEJM) on August 21, 2025. This publication in a highly respected medical journal provides significant validation for MOLBREEVI.
The manuscript, titled 'A Phase 3 Trial of Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis,' will detail that molgramostim reduced pulmonary surfactant burden and improved pulmonary gas transfer, respiratory health-related quality of life, and patient functionality. The trial achieved statistical significance on its primary endpoint, change from baseline in hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide (DLco%) at Week 24 (9.8% vs. 3.8%; estimated treatment difference, 6.0%; P<0.001).
The beneficial effect on DLco% was maintained to Week 48 (11.6% vs. 4.7%; estimated treatment difference, 6.9%; P<0.001). Molgramostim also improved respiratory health-related quality of life (SGRQ Total score -11.5 points vs. -4.9 points, P=0.007 at Week 24) and patient function (peak-METs 1.1 vs. 0.6 at Week 48). The drug was well tolerated, with 98% of patients in the molgramostim group completing the 48-week double-blind period.
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