Savara Inc. released a corporate presentation highlighting its focus on autoimmune pulmonary alveolar proteinosis (autoimmune PAP), a rare chronic lung disease caused by GM-CSF autoantibodies that impair surfactant clearance and can lead to hypoxemic respiratory failure. The company outlines that there are no approved drugs in the U.S. or Europe for autoimmune PAP and that whole lung lavage remains an invasive, non-standardized treatment that may need to be repeated. The presentation includes an overview of MOLBREEVI (molgramostim inhalation solution), an investigational drug-device product administered once daily via a proprietary eFlow nebulizer system. Savara summarizes Phase 3 IMPALA-2 data showing improvements versus placebo in the primary endpoint of change from baseline in DLCO% at Week 24 (p=0.0007) and a secondary endpoint at Week 48 (p=0.0008), along with reported changes in patient-reported outcomes and exercise capacity measures. Savara also notes that the FDA accepted its BLA for filing. You can access the full presentation through the link below.
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