Biotech Tracker News - Publication Confirms Impact of Antegren in Crohn Disease
January 02, 2003 Wednesday’s issue of The New England Journal of Medicine features data from a 248-patient, randomized, double-blind, placebo-controlled, Crohn disease trial demonstrating that Biogen (NASDAQ: BGEN) and Élan’s (NYSE: ELN) Antegren (natalizumab) failed to meet its primary endpoint of remission at 6 weeks, but was able to meet clinically significant endpoints of clinical remission at multiple time points and quality of life advantages. The published results rigorously confirm earlier data presentations. The mixed but clinically important data support continued, ongoing, larger-scale, phase III investigations of Antegren for Crohn disease.  The Natalizumab Pan-European Study Group conducted a randomized, double-blind, placebo-controlled trial of Antegren in patients with moderate-to-severe Crohn disease. Study subjects were randomly assigned to receive one of four treatment arms:  two infusions of placebo  one infusion of Antegren 3 mg/kg followed by placebo  two infusions of Antegren 3 mg/kg  two infusions of Antegren 6 mg/kg.  Infusions were administered four weeks apart. Primary and secondary outcomes included changes in scores for the Crohn’s Disease Activity Index (CDAI, higher scores=more severe disease), health-related quality of life (HRQOL), and C-reactive protein levels.  The study did not meet its primary efficacy endpoint because group 4 did not achieve a significantly higher rate of clinical remission (< 150 on CDAI) than group 1 at week 6. Nevertheless, groups 3 and 4 achieved significantly higher remission rates than group (1) at multiple time points. Antegren also produced clinically significant response rate improvements (reduction of at least 70 points on CDAI). The highest remission rate was 44% and the highest response rate was 71% (at week 6 in group 3). Similar clinical effects were observed for groups 3 and 4. HRQOL improved in all Antegren groups. C-reactive protein levels improved in groups 3 and 4. Antegren’s adverse effect and tolerability profile was reassuring.  Crohn disease is in part characterized by inflammatory gut lesions arising from autoimmune responses that involve activated inflammatory cells that express glycoprotein a4-integrin on their surfaces. a4-integrin helps circulating inflammatory cells adhere to blood vessels in a manner that facilitates their extravasation into tissue where they can wreak havoc. Antegren is a monoclonal antibody that binds to a4-integrin, preventing it from binding to its ligand and blocking its biological effects. Biogen and Élan hope that this mechanism of action can spare enough gut cells in Crohn disease to be clinically useful.  Biogen and Élan are also developing Antegren for multiple sclerosis, in which a4-integrin mediated inflammation is also implicated. The multiple sclerosis studies have shown that Antegren can impact brain lesions in the disease, but have yet to demonstrate that this translates into significantly improved patient function and performance.
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