More Phase III Antegren data

Elan (ELN) and Biogen Idec (BIIB) said that in the ENACT-2 Phase III maintenance trial in 339 moderate to severe Crohn's disease patients, 61% of patients given Antegren natalizumab continued to respond to therapy for six months, the primary endpoint, compared with 29% for placebo (p<0.001). Also, 44% of Antegren patients maintained clinical remission, compared with 26% of placebo patients (p=0.003). There were no notable differences in adverse events between the two arms. Data were presented at the Digestive Disease Week meeting in New Orleans.

ENACT-2 enrolled responders from ENACT-1. In ENACT-1, a double-blind Phase III trial in 905 moderate to severe Crohn's patients, Antegren missed the primary endpoint of response as defined by a 70-point decrease in the CDAI score at week 10 (see BioCentury Extra, Thursday July 24, 2003). ...