Antegren hits roadblock in Crohn's trial...

...but its MS trials are still on track. Biogen's experimental drug Antegren, which is in Phase III trials for MS and Crohn's disease, failed to meet the primary study goals of the ENACT-1 trial in Crohn's patients, according to a press release from the company. The response to the drug at week 10 (as measured by a decrease in the Crohn's Disease Activity Index) did not meet the study target. This may be due to a larger than expected response in the placebo group, which in turn may have been caused by a 4:1 drug to placebo ratio leading people in the placebo group to have greater expectations that they were receiving active treatment.

A few bright spots did emerge from the study, including reduction of inflammatory markers and significant benefits in a subset of participants with active inflammation. Also, side effects were similar between the treatment and placebo groups.

Biogen is going to meet with the FDA to review the implications of the results of this trial. In the meantime, a trial of Antegren as a continuous therapy for Crohn's disease is still underway, as are the MS trials AFFIRM (Antegren in relapsing-remitting MS) and SENTINEL (Antegren plus Avonex in relapsing-remitting MS).