AG019 PK analysis
AG019 bacteria were not detected in blood by plating or by qPCR, nor were there indications of AG019-related hPINS or hIL-10 in plasma measured by ELISA, either during treatment or 1 month after the last dose of AG019 (day 90).Twenty-five participants (nine high-dose AG019-treated, 13 AG019/teplizumab-treated and three placebo-treated) provided faecal samples. AG019 bacteria were detected in faecal samples of 18/22 (82%) repeat-dose participants treated with AG019 high-dose monotherapy or AG019/teplizumab combination therapy at one or more post-screening sampling timepoints, indicating GI exposure to AG019 after oral dosing (Fig. Concentrations of AG019 bacteria in faecal samples collected after the last day of AG019 dosing (day 56) from participants treated with (On day 64 (1 week after last AG019 dosing), AG019 was undetectable in 11/15 (73%) of the participants who provided a sample and had detectable levels of AG019 bacteria at one or more earlier timepoints. AG019 levels were detectable but strongly decreased (mean 2.9 log decrease from peak levels) in the other four participants.