The study is designed to enroll over 200 patients with relapsing-remitting MS who have failed earlier treatment with a beta-interferon.
Last October the companies entered an agreement to co-develop and co-commercialize the small molecule compound, CDP323.
The trial compares the safety and efficacy of two doses of CDP323 monotherapy to placebo over a period of six months. This is the first time that patients with MS will be exposed to CDP323. Approximately 50 medical centers in Europe and the US are expected to participate in this study. The results of this phase II study are expected by the end of 2008.
“Multiple sclerosis affects more than a million people worldwide and so far, no oral treatment has been available. An oral therapy would represent a significant advance for patients as it could provide them with a new, non-invasive option of drug delivery,” said professor Chris Polman, professor of neurology, VU Medical Center, Amsterdam and lead investigator for this study.