Asphelia Trichuris Suis Ova in Moderately Active Crohn's Disease

Inflammatory bowel disease (IBD) is a chronic, relapsing condition of the gastrointestinal (GI) tract. IBD is thought to result from inappropriate T cell activation due to a combination of genetic and environmental factors. This leads to a deregulated immune response and characteristic inflammation. Crohn’s disease (CD) is a form of IBD. One theory suggests that underexposure to helminths is a major environmental factor in predisposing to CD. This “hygiene hypothesis” is based on epidemiologic findings of an inverse relationship between IBD incidence and helminthic colonization. In the proposed study, the pig whipworm Trichuris suis (T. suis), formulated as ASP1002 [Trichuris suis Ova (TSO)], a suspension for oral administration, will be administered in the clinic as a single dose for 6 times. T. suis is similar morphologically to the human whipworm but is cleared too rapidly from the human host to establish infection. Therefore, it has potential for being a natural immune modulator without significant risk of causing disease in humans. The expected duration of study participation is approximately 26 to 27 weeks, including up to 2 - 3 weeks screening, a 12 week treatment period and a follow-up visit at Week 24.