Molgramostim shows significant lung function and quality of life improvements in 48-week study for aPAP
Savara announced positive data from its Phase 3 IMPALA-2 trial of molgramostim, a nebulizer solution for treating autoimmune pulmonary alveolar proteinosis (aPAP).
The IMPALA-2 trial showed promising results for molgramostim in treating lung conditions. At Week 24, the primary goal of improving lung function (measured by DLCO%) was met, and this improvement lasted until Week 48. In addition, molgramostim showed significant benefits in improving quality of life (SGRQ scores) and exercise capacity. Most patients tolerated the treatment well, with 97% completing the 48-week period, and only 2 discontinuing due to unrelated adverse events. All who finished the double-blind trial chose to continue in the open-label extension.
Further results highlighted included:
- Significant improvement in symptoms and oxygen levels were noted at Weeks 24 and 48 with molgramostim.
- A greater proportion of patients responded positively with molgramostim compared to placebo at Weeks 24 and 48.
- More patients saw meaningful quality of life improvements with molgramostim, especially at Week 48.
- Ground Glass Opacification (GGO) score was significantly better with molgramostim at Week 24.
Overall, molgramostim demonstrated a strong benefit and safety profile in the trial.
“The IMPALA-2 results demonstrate molgramostim’s ability to correct the pathobiology causing aPAP lung disease and improve its cardinal manifestations,” said Bruce Trapnell, MD, Professor of Medicine and Pediatrics at the University of Cincinnati College of Medicine and the Lead Clinical Investigator of the IMPALA-2 trial in a press release. “Specifically, molgramostim reduced surfactant burden, increased pulmonary gas transfer, improved health-related quality of life, increased exercise capacity, and was well-tolerated in patients with aPAP.”
Read the full press release here.
