Anti-Bacillus Anthracis PA Recombinant Antibody (Obiltoxaximab) (CAT#: TAB-440CQ)

Figure 1 Mean (SD) plasma obiltoxaximab con-centration-time profile through 191days in the pharmacokinetic popula-tion (N ¼69) of study 5.

Subjectsreceived a single 16-mg/kg dose ofobiltoxaximab on day 1 and day 14in group 1 and on day 1 and day 120in group 2. One subject from group 1was excluded from concentration-timesummary statistics. For group 2, n ¼35 for day 1 and n ¼31 for day 120.Group 2 concentration-time curves ondays 1 and 120 are overlapping todemonstrate that they are superimpo-sable. A, Linear scale; B, log scale.

Nagy, C. F., Leach, T. S., Hoffman, J. H., Czech, A., Carpenter, S. E., & Guttendorf, R. (2016). Pharmacokinetics and tolerability of obiltoxaximab: A report of 5 healthy volunteer studies. Clinical therapeutics, 38(9), 2083-2097.

Figure 2 Obiltoxaximab mean (SD) Cmax (a) and AUC(0‐48) (b) as a function of dose in healthy and infected monkeys.

AUC over the first 48 h (AUC0‐48) was chosen so as to effect a meaningful evaluation across all of the animal groups (healthy; infected survivors; infected nonsurvivors). There were too few animals with a valid estimate of AUC from time 0 extrapolated to infinity (AUC0‐inf), particularly in nonsurviving infected animals, to make a useful comparison with this parameter.

Nagy, C. F., Mondick, J., Serbina, N., Casey, L. S., Carpenter, S. E., French, J., & Guttendorf, R. (2017). Animal‐to‐Human Dose Translation of Obiltoxaximab for Treatment of Inhalational Anthrax Under the US FDA Animal Rule. Clinical and translational science, 10(1), 12-19.