DUBLIN, Ireland ¿ Elan Corp. plc and Biogen Inc. are planning to move their humanized monoclonal antibody treatment, Antegren, into Phase III trials for two indications before the end of the year. Recruitment for a multiple sclerosis study already has commenced.
¿The study will begin in the fall,¿ Dublin-based Elan¿s chief scientific and medical officer, Ivan Leiberburg, told BioWorld International. The Crohn¿s disease trial will follow a similar schedule.
These moves follow the disclosure of positive Phase II data for MS in January and for Crohn¿s disease in May. Assuming success in both sets of studies, Leiberburg said he expects an earlier NDA filing for the latter indication. The criteria for acceptance of a new Crohn¿s disease therapy include one year on drug and a demonstrated remission based on the Crohn¿s Disease Activity Index.
As yet, it is not clear what the accepted endpoints are for the MS studies. It may be sufficient to show a reduction in the number of relapses or flares to gain approval, with a follow-up demonstration of an improvement in the Expanded Disability Status Score, a measure of disability levels in MS patients. If EDSS data are required for the NDA filing, it could add an extra year to the study period. ¿That is really a discussion that is taking place with the FDA right now,¿ Leiberburg said.
The MS studies will comprise two separate Phase III trials. A trial of Antegren as a monotherapy will be conducted in Europe, while a combination study involving Cambridge, Mass.-based Biogen Inc.¿s beta-interferon blockbuster Avonex will take place in the U.S. Leiberburg said he expects the effects of the two drugs to be additive, if not synergistic. ¿There is no reason to suspect the drugs would not be compatible,¿ he said.