Phase II has started and, interestingly, it is for sufferers for whom interferon has failed.
UCB and Biogen Idec's Oral VLA-4 Antagonist Enters Phase II Development for MS 26 June 2007
UCB and Biogen Idec today announced the initiation of a Phase II study of CDP323 - an oral VLA-4 antagonist - under development for relapsing-remitting multiple sclerosis (MS). The double-blind, randomised Phase II study commenced this week with dosing of the first patient.
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-commercialise this small molecule compound.
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 U.S. 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 Centre, Amsterdam, the Netherlands, Lead Investigator for this study.
CDP323 is an orally active small molecule VLA-4 antagonist. The safety, tolerability and pharmacokinetic profile of CDP323 have been evaluated in healthy volunteers in three separate Phase I studies. Data from these studies were reported at the 2006 European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The data from these early studies supports further development of CDP323.
Source: UCB and Biogen Idec(26/06/07)