BioCentury
ARTICLE | Product Development

Maintaining hope for Antegren

July 28, 2003 7:00 AM UTC

Though Antegren natalizumab from Biogen Inc. and Elan Corp. plc failed to meet the primary endpoint in a Phase III study, it is too soon to pass judgement on its utility for Crohn's disease. A high placebo response, a problem that has plagued other trials in the indication, might have masked the pharmacologic activity aimed at inducing a disease response. And it remains to be seen whether the compound will be effective as maintenance therapy.

In the ENACT-1 trial in 905 patients with moderate-to-severe disease, those taking 300 mg of Antegren did not show an increased rate of response as defined by a 70-point decrease in the Crohn's Disease Activity Index score at week 10 compared to those taking placebo. Patients were dosed at weeks 0, 4 and 8. ...