Figure 3. Plots of individual patient PD data over time.
After administration of BPS804, mean ALP enzymatic activity (A) increased between days 2 and 29 after the third infusion compared with baseline. (B) Similarly, for BSAP, the enzymatic activity increased between days 2 and 29 after the third infusion compared with baseline. Individual BSAP values for patient 4 (screening, EoS) and patient 5 (days 1, 2, 8, 85, and 133 and EoS) were below the LOQ and are not represented in the graph. (C) PEA levels showed inter-individual variability; thus, changes during treatment are given as ratio versus individual baseline. (D) PLP values showed large intra- and inter-patient variability. A consistent decline upon treatment was seen in patients 4 and 5, who had the highest baseline values. Vertical lines indicate time of infusion (days 1, 15, and 29). Shaded area indicates the time period of days 2–29 after the third infusion. Horizontal lines indicate lower normal limit for ALP by sex in A, LOQ in B, and normalized baseline in C. The y axis in C and D is broken to include outliers and still clearly visualize lower individual PEA/PLP levels.