In a second phase III trial (CONFIRM), Biogen Idec’s oral BG-12 (dimethyl fumarate) demonstrated efficacy across a variety of clinical and radiological outcome measures, as well as favorable safety and tolerability profiles in patients with relapsing-remitting multiple sclerosis (RRMS).
CONFIRM was a global, placebo-controlled clinical trial to determine the efficacy and safety of 240mg of BG-12, administered either twice a day (BID) or three times a day (TID), in people with RRMS. The study included glatiramer acetate (GA; 20mg subcutaneous daily injection) as a reference comparator. Both active treatments were compared to placebo.
BG-12 met the CONFIRM study's primary endpoint by significantly reducing annualized relapse rate (ARR) by 44% for BID and by 51% for TID (p
BG-12 met the study's secondary relapse endpoint by significantly reducing the proportion of patients who relapsed at two years by 34% for BID (p=0.0020) and by 45% for TID (p<0.0001) compared to placebo. GA provided a 29% reduction (p=0.0097) in the proportion of relapsing patients compared to placebo over the same time period.
BG-12 also met magnetic resonance imaging (MRI) endpoints in a cohort of patients, demonstrating a significant effect on MS brain lesions. Reductions in new brain lesion counts were evident within the first year of treatment and were sustained throughout the study.
At two years compared to placebo:
Results from CONFIRM also showed that BG-12 reduced the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 21% for BID (p=0.2536) and by 24% for TID (p=0.2041) at two years compared to placebo, while GA reduced the risk of confirmed disability progression by 7% (p=0.7036).
These data, along with results from BG-12's first phase III study, DEFINE, were included in regulatory applications that were submitted to U.S. and E.U. 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 patients," said Douglas E. Williams, Ph.D., executive vice president of R&D at Biogen Idec. "If approved by regulators, we believe BG-12 could be an important new oral therapeutic option for MS patients."