SVRA
Live News • May 22
Savara Phase 3 Data Shows Molgramostim Boosts Exercise Capacity and Biomarkers in aPAP Patients Savara reported new Phase 3 IMPALA-2 data showing that molgramostim inhalation solution for autoimmune pulmonary alveolar proteinosis (aPAP) led to statistically significant gains in exercise distance and exercise duration at Week 48 versus placebo.
The trial also showed statistically significant improvements in pulmonary gas transfer for patients receiving molgramostim compared with placebo.
Molgramostim treatment was associated with reduced serum biomarker levels tied to disease severity, and these reductions correlated with better functional lung outcomes.
The alignment between clinical endpoints such as exercise capacity and biomarker changes points to a more complete picture of potential treatment benefit for aPAP.
For investors, the key question from here is how these data may support regulatory discussions, potential labeling, and ultimately physician adoption and payer coverage if molgramostim progresses toward commercialization. Announcement • May 20
Savara Inc Announces New Exercise Capacity Data From The IMPALA-2 Phase 3 Clinical Trial Of Molgramostim Inhalation Solution In Autoimmune Pulmonary Alveolar Proteinosis Savara Inc. sponsored an oral presentation at the ATS 2026 International Conference that is taking place May 15-20, 2026, in Orlando, Florida. The presentation reported new exercise capacity data from the double-blind period of the IMPALA-2 Phase 3 clinical trial evaluating molgramostim for the treatment of autoimmune pulmonary alveolar proteinosis. Presented exercise capacity data from IMPALA-2, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial in which adults with autoimmune pulmonary alveolar proteinosis received nebulized molgramostim 300 µg (n=81) or placebo (n=83) once daily for 48 weeks. IMPALA-2 achieved statistical significance on its primary endpoint and other secondary endpoints, including a greater mean improvement in exercise capacity, expressed as peak metabolic equivalents (METs), in the molgramostim group at 48 weeks. This oral presentation reported on the effects of molgramostim on exploratory endpoints of exercise distance and duration, assessed at Weeks 24 and 48 via a conservative, ramp-up, symptom-limited, exercise treadmill test. Greater mean improvement in distance walked was observed in molgramostim-treated patients compared with placebo at Week 48. The least-squares mean (LSM) change in distance walked from baseline to Week 48 was 167.0 m (95% confidence interval [CI], 112.1 to 221.8) in the molgramostim group and 86.4 m (95% CI, 32.4 to 140.4) in the placebo group, yielding an estimated treatment difference of 80.6 m (P=0.0301). Molgramostim patients were also able to exercise for longer periods of time compared with patients who received placebo. At Week 48, the LSM change in duration of exercise from baseline was 2.0 minutes (95% CI, 1.3 to 2.7) in the molgramostim group and 1.0 minute (95% CI, 0.3 to 1.6) in the placebo group, yielding an estimated treatment difference of 1.0 minute (P=0.0262). Consistent with improvements in peak METs, molgramostim improved both distance walked and duration of exercise at Week 48 compared with placebo, supporting the potential clinical benefit of molgramostim treatment in patients with autoimmune pulmonary alveolar proteinosis. The full content of this poster will be available on the Congresses and Publications page of the Savara corporate website. The abstract is published in a supplement of the American Journal of Respiratory and Critical Care Medicine. 
