Psoriasis can profoundly impact a patient's quality of life, causing disability of physical and mental functioning comparable to other major medical diseases such as type 2 diabetes, hypertension, myocardial infarction, depression, and arthritis. It is also associated with serious co-morbidities, including psoriatic arthritis, depression, malignancy, metabolic syndrome, cardiovascular morbidity and mortality. While many patients with mild disease are able to control psoriasis symptoms with topical medications alone, patients with moderate to severe disease usually require treatment with systemic agents to achieve good clearance. These systemic agents are usually well tolerated, but can have potentially significant side effects including organ toxicity, infection, malignancy, and teratogenicity that limit their usefulness in the long-term management of psoriasis.
Biologic agents have been a significant advancement in the treatment of moderate to severe psoriasis, but can have limited and/or diminishing efficacy and require administration by subcutaneous injection or intravenous infusion. These agents are still relatively new and long term safety issues (e.g., infection including tuberculosis, malignancies including lymphoma, and demyelinating neurologic events) are not fully understood. Despite all the available treatments, there is still a need for therapies that will provide high continuous efficacy, improved safety, and a more convenient route of administration to maximize compliance and satisfaction with treatment, leading to decreased burden of the disease.
TSO ( Trichuris suis ova or CNDO-201), the microscopic eggs of the porcine whipworm, is a novel, orally administered, natural immunomodulator that regulates T-Cells and pro-inflammatory cytokines. The use of TSO as a therapeutic is based on the "hygiene hypothesis" and numerous animal and human studies. TSO was chosen as the biological agent of choice because it is not a human pathogen, and is spontaneously eliminated from the body within several weeks after dosing.In February 2012, the company reported positive results from a phase 1 clinical study of TSO in patients with Crohn's disease, where TSO was shown to be safe and well tolerated. The phase 1 trial was a multi-center, sequential dose, dose-escalation, double-blind, placebo-controlled study of 36 patients with Crohn's disease. In August 2012, Coronado initiated TRUST- I (TRichUris Suis ova Trial), a phase 2 clinical trial of TSO in patients with Crohn's disease in the United States, which is expected to be completed in the second half of 2013.