The latest trial study from Savara Inc ( SVRA ) met its primary endpoint.

The company released results from Phase 3 IMPALA-2 trial of molgramostim 300 mcg administered once daily by inhalation with a matching placebo for autoimmune pulmonary alveolar proteinosis (aPAP).

Matt Pauls, CEO Savara, praised the results.

PAP is a rare lung disease caused by a buildup of proteins, fats, and other substances in the lungs’ air sacs (alveoli).

Molgramostim is an inhaled form of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF).

The treatment difference between molgramostim and placebo for mean change from baseline to Week 24 in hemoglobin-adjusted percent predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) achieved statistical significance, with a change of 6%.

The DLCO test measures how much carbon monoxide passes from your lungs to the blood.

This statistically significant treatment difference was sustained at Week 48, a secondary endpoint, with a change of 6.90%, demonstrating the durability of the effect.

The treatment difference between molgramostim and placebo for mean change from baseline to Week 24 in St. George’s Respiratory Questionnaire Total Score (SGRQ) achieved statistical significance.

SGRQ is a standardized self-completed questionnaire measuring impaired health and perceived well-being (‘quality of life’) in airway disease. A negative change from baseline corresponds to improvement.

The SGRQ total score at 24 weeks was -6.59 and -4.87 at 48 weeks.

Two additional secondary endpoints reached nominal significance: SGRQ Activity Score at Week 24 and exercise capacity using a treadmill test at Week 48.

SGRQ Activity assesses the patient’s ability to carry out daily physical activity.

SGRQ Activity Score at 24 weeks was -7.81 and -5.99 at 48 weeks.

Molgramostim was well tolerated. The frequency of adverse events was generally similar between treatment groups.

Two patients (2.5%) discontinued molgramostim treatment due to adverse events, both of which were considered unrelated to the trial drug.

Price Action: SVRA shares are up 30% at $4.94 during the premarket session at last check Wednesday.

Now Read: Sanofi Looks To Sell $20B Icy Hot Division: Likely Bidders Include Advent, PAI Partners, Blackstone, CVC