The drug's producers, Elan Corporation plc and Biogen Inc, are proceeding to initiate Phase III studies this year.
The double-blind placebo controlled study was conducted across 38 sites in 8 European countries and included 240 patients with moderate to severe Crohn's Disease.
Patients received doses of Antegren or placebo at week 0 and week 4.
The study demonstrated statistically significant positive results on multiple endpoints, including induction of remission as measured by the Crohn's Disease Activity Index.
|Antegren is a humanized monoclonal antibody that binds to alpha-4-beta-1 (VLA-4) and alpha- 4-beta-7 receptors.|
|Elan Corporation plc|
Antegren is a humanized monoclonal antibody and the first in a new class of potential therapeutics known as alpha-4 integrin inhibitors that are designed to block immune cell adhesion to blood vessel walls and subsequent migration of lymphocytes into tissue. Antegren binds to the cell surface receptors known as alpha-4-beta-1 (VLA-4) and alpha- 4-beta-7.
Antegren may be useful in the treatment of a range of inflammatory and non-inflammatory diseases.
Further information about the potential safety and efficacy of the drug will be presented at a scientific conference later this year.
Donal J. Geaney, Elan's chairman and chief executive officer, said, "We are delighted that these positive results support the continued and accelerated development of Antegren as a potentially important new therapy for the treatment of Crohn's disease. In conjunction with Biogen, we look forward to advancing Antegren into Phase III studies."