Shigamabs™ Phase II Study Design
The randomized, double-blind, placebo-controlled trial will enroll 42 patients aged six months to 18 years testing positive for STEC infection, distributed in two cohorts. The first cohort will compare standard of care combined with a low dose of Shigamabs® (1 mg/kg) versus standard of care with placebo, followed by an interim analysis of data for safety conducted by an Independent Data Monitoring Committee (IDMC). Following a positive recommendation to proceed by the IDMC, the second cohort will compare standard of care combined with a high dose of Shigamabs® (3 mg/kg) versus standard of care with placebo. The primary endpoints for the Phase II trial are safety and tolerability. Secondary endpoints include pharmacokinetics and objective measures of efficacy using single and composite endpoints. Data from the core study is expected within 9-12 months, with long term safety data available after a one year follow-up period.
