TSO is a microscopic egg of the porcine whipworm that is administered orally to regulate T-Cells and inflammatory cytokines.
Coronado president and CEO Bobby W. Sandage, Jr said previous investigator-initiated trials have demonstrated TSO’s therapeutic potential to induce response and remission rates in inflammatory bowel disease patients.
"This Phase 2 study will expand our understanding of TSO’s clinical usefulness in patients with moderately to severely active Crohn’s disease," Sandage, Jr added.
The randomized, double-blind and placebo-controlled study is designed to gauge the safety and efficacy of TSO.
Nearly 220 Crohn disease patients will be enrolled and randomized to administer either 7500 ova or placebo once every 2 weeks, for 12 weeks.
The focus of the study is induction of response as measured by the Crohn’s Disease Activity Index (CDAI).
Coronado executive vice president and chief medical officer Karin Hehenberger said the use of TSO in the treatment of Crohn disease and other autoimmune disorders is based on the hygiene hypothesis, which suggests the immune systems of people living in developed countries with little or no exposure to parasites may not be able to properly regulate themselves.
”This hypothesis is further supported by epidemiologic findings of an inverse relationship between autoimmune diseases and helminthic colonization, as well as pre-clinical data in different disease models," Hehenberger added.