Thallion reports low dose cohort Phase II Shigatec study results

Two-thirds of the enrolled patients were less than four years old.

Shigamabs consists of two monoclonal antibodies which bind to the Shiga toxin 1 and Shiga toxin 2 toxins secreted by Shiga toxin- producing E. coli bacteria.

The majority of the infections were assigned to non-O157 E. coli strains, with a predominance of Shiga toxin 2 producers.

Thallion CEO Allan Mandelzys said they continue to be encouraged by the consistency of the Shigamabs safety results across studies.

The company plans to initiate the double-blind, placebo-controlled, randomized trial which will enroll 42 patients, aged six months to 18 years with positive STEC infection.

The trial will compare standard of care combined with a single 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.