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) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that new data from the Phase 3 IMPALA-2 clinical trial of molgramostim in patients with autoimmune Pulmonary Alveolar Proteinosis (aPAP) were presented at the European Respiratory Society (ERS) Congress 2024 in Vienna, Austria. The poster from this presentation can be found here.

As previously announced, the IMPALA-2 trial met its primary endpoint, achieving statistical significance in change from baseline in hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO%) at Week 24. This statistically significant treatment difference was sustained through Week 48, a secondary endpoint, which demonstrated durability of effect. The treatment difference between molgramostim and placebo for mean change from baseline to Week 24 in SGRQ Total Score, a secondary endpoint, achieved statistical significance. Two additional secondary endpoints reached nominal significance: SGRQ Activity Score at Week 24 and exercise capacity using a treadmill test at Week 48. Molgramostim was well tolerated and demonstrated a favorable benefit/risk profile in the IMPALA-2 trial. In addition, 97% of patients completed the 48-week double-blind treatment period, with only 2 patients discontinuing molgramostim due to adverse events which were assessed by the investigator as not related to study treatment. One hundred percent of the patients who completed the double-blind period elected to participate in the 96-week open-label period.

New disease severity, responder analyses, and other results measuring surfactant burden presented today at ERS, and summarized below, further support the beneficial effects of molgramostim compared with placebo.

Disease Severity Score (DSS)

The mean change from baseline in disease severity score, which reflects symptoms and arterial partial pressure of oxygen, was significantly more improved at Weeks 24 and 48 with molgramostim compared with placebo.

DLCO% Responder Analysis

Results from a DLCO% responder analysis demonstrated significantly higher proportions of responders with molgramostim compared with placebo at Weeks 24 and 48. Odds ratios were determined for patients achieving ≥ 5, 7, and 10 percentage point improvements in DLCO% from baseline.

St. George’s Respiratory Questionnaire (SGRQ) Total Score Responder Analysis

Results from an SGRQ Total Score responder analysis showed that numerically (at Week 24) and significantly (at Week 48) higher proportions of patients achieved each responder threshold of ≥ 4-, 8-, and 12-point improvements with molgramostim compared to placebo.