Clinical Data Lung Function ResultsAnalysis of the lung functions in the safety population as described below indicate that after one year of daily inhalation of Kamada’s AAT, clinically and statistically significant improvements were seen in spirometric measures of lung function, particularly in bronchial airflow measurements FEV1 (L), FEV1% predicted and FEV1/SVC.For lung function overall one-year effect:  

• FEV1 (L) rose significantly in AAT-treated patients and decreased in placebo-treated patients (+15ml for AAT vs. -27ml for placebo, a 42 ml difference, p=0.0268)
• There was a trend towards better FEV1% predicted (0.54% for AAT vs. -0.62% for placebo, a 1.16% difference, p=0.065)
• FEV1/SVC% rose significantly in AAT-treated patients and decreased in placebo-treated patients (0.62% for AAT vs. -0.87% for placebo, a 1.49% difference, p=0.0074)

For lung function change at week 50 vs. baseline:

• There was a trend towards reduced FEV1 (L) decline (-12ml for AAT vs. -62ml for placebo, a 50 ml difference, p=0.0956)
• There was a trend towards a reduced decline in FEV1% predicted (-0.1323% for AAT vs. -1.6205% for placebo, a 1.4882% difference, p=0.1032)
• FEV1/SVC% rose significantly in AAT-treated patients and decreased in placebo-treated patients (0.61% for AAT vs. -1.07% for placebo, a 1.68% difference, p=0.013)