Positive Ph III data for Biogen Idec's oral MS drug candidate BG-12

US biotech firm Biogen Idec (Nasdaq: BIIB) says that detailed positive data from CONFIRM, the second Phase III clinical trial of oral BG-12 (dimethyl fumarate) in people with relapsing-remitting multiple sclerosis (RRMS), will be presented in three platform presentations at the 64th Annual Meeting of the American Academy of Neurology (AAN) in New Orleans.

In CONFIRM, BG-12 demonstrated efficacy across a variety of clinical and radiological outcome measures, as well as favorable safety and tolerability profiles. These data, along with results from BG-12’s first Phase III study, DEFINE, were included in regulatory applications that were submitted to US and European Union regulatory agencies early this year.

“Results from CONFIRM complement the profile we have seen for BG-12 throughout its clinical development program, which now includes robust data sets from two global, placebo-controlled Phase III pivotal studies with more than 2,600 multiple sclerosis (MS) patients,” said Douglas E. Williams, Biogen Idec’s executive vice president of R&D. “If approved by regulators, we believe BG-12 could be an important new oral therapeutic option for MS patients,” he added.