AI Article Synopsis
- The study investigates the use of embryonated eggs of the pig whipworm (Trichuris suis) as a pharmaceutical treatment for immune-mediated diseases in humans.
- Researchers tested various doses of T. suis eggs in minipigs to assess the relationship between the dose and the establishment of larvae in the intestines.
- Results showed a clear dose-response relationship, indicating that the minipig model is effective for evaluating the biological potency of TSO, with consistent larval recovery across different groups.
Article Abstract
Embryonated eggs of the pig whipworm Trichuris suis (TSOee) constitute the active pharmaceutical ingredient (API) in a medicinal product explored in human clinical trials against several immune-mediated diseases. The measurement of TSO biological potency (hatchability and infectivity) is a requirement for the assessment of TSO's pharmacological potency in human clinical trials. The present study aims to validate the dose-dependent establishment of T. suis larvae in Göttingen minipigs and eventual clinical implication of a dose range (1000-10,000 TSO). Four groups of 5 minipigs were inoculated with doses of 1000, 2500, 7500, and 10,000 TSOee, respectively, to evaluate a range of concentrations of TSOee in a minipig infectivity model. Unembryonated eggs (TSOue) were added to keep the total egg number in the inoculum constant at 10,000 eggs. Two groups received 2500 and 7500 TSOee per pig without the addition of TSOue as controls. The intestinal larval establishment at 21 days post inoculation (dpi) demonstrated a clear positive linear dose-response relationship between numbers of inoculated TSOee and recovered larvae. There was a low level of variation in larval counts in all study groups. Thus, the infectivity model in minipigs within the tested dose range offers a reliable, sensitive and accurate assay for testing biological potency of TSO.
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| http://dx.doi.org/10.1016/j.vetpar.2015.01.018 | DOI Listing |
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