Assessing LAAD Expression Effect on Phe Metabolism

Example 74

Efficacy of of LAAD expression and determination of any negative effects on PAL metabolism of Phe was assessed.

At T=0, the urine pan was emptied, and Non-Human Primates (NHPs) were orally administered 5.5 g of Peptone from meat in 11 mL, and 10 mL of an oral gavage bacteria. A SYN-PKU-2001 (5×10¹¹ CFU) oral gavage bacteria strain was administered to NHP's 1-3. A SYN-PKU-2001 (5×10¹¹ CFU) without LAAD was administered to NHP's 4-6. Both strains were suspended in formulation buffer (previously grown in activated in a bioreactor and thawed on ice) or formulation buffer alone as a mock. Concurrently, NHP's 1-10 were all administered 5 mL of 0.36M sodium bicarbonate followed by a flush with 5 mL of water Animals were bled at 0, 0.5, 1, 2, 4, and 6 h by venipuncture. At 6 h post dosing, the urine collection pan was removed and the contents poured into a graduated cylinder for volume measurement of 5 mL. Results are shown in FIG. 24A and FIG. 24B confirm that expression of LAAD did not have a negative effect on PAL metabolism of Phe.