Thallion Pharmaceuticals has enrolled the first patient in the high-dose cohort of its Phase II SHIGATEC trial, which will evaluate Shigamabs as a treatment for E coli infections that produce shiga toxins.
The randomised, double-blind and placebo-controlled trial will involve 42 patients aged six months to 18 years old who have tested positive for such infections, distributed in two cohorts.
The first cohort will compare the standard of care plus placebo to standard of care plus a low dose of Shigamabs, while the second cohort will compare the standard of care plus placebo to a high dose of Shigamabs plus placebo.
The primary endpoints for the Phase II trial are safety and tolerability, while secondary endpoints include pharmacokinetics and measures of efficacy using single and composite endpoints.
