Multiple Sclerosis, MS, is a lifelong, chronic autoimmune disease where the immune system attacks the body's myelin. The myelin sheath insulates the axons of nerve fibers. MS results in inflammation and demyelination. When myelin is damaged, messages between the brain and other parts of the body are disrupted. The disease can cause a range of symptoms, which appear as flare-ups of various symptoms including: seizures, motor impairment, cognitive problems, depression, anxiety, visual impairment, swallowing and bowel problems. Treatments for MS include interferon beta 1-a (Avonex®, Rebif®), interferon beta 1-b (Betaseron®), mitoxantrone (Novantrone®) and natalizumab (Tysabri®). Most of the treatments involve injection and/or high cost of goods along with limited efficacy, providing Tranilast a clear differential and strong market opportunity. One of the most promising agents in the treatment for MS, Tysabri, was recently removed from the market after severe adverse events were reported following its use. Now available via a special access program, its use is being carefully monitored. Currently, there is no effective oral agent for MS.
Worldwide around 3.5 million people have MS with almost 400,000 in the U.S.
Nuon Therapeutics' lead program addresses the clear unmet need for an effective oral agent to address Multiple Sclerosis. Based upon preclinical studies, Tranilast, a small-molecule, orally available drug, has shown efficacy in industry standard preclinical animal models of MS (the mouse EAE model). In these studies, Tranilast has been compared with positive controls and evaluated using multiple endpoints demonstrating superiority in most applications to class leading compounds. In these studies, Tranilast showed efficacy in reversing established disease and dramatically improved symptoms at plasma levels lower than those seen in human clinical trials. Nuon Therapeutics anticipates initiating US clinical trials in early 2008.