Biogen Idec's oral BG-12 (dimethyl fumarate) drug demonstrated safety and efficacy data in the second Phase 3 Comparator and an Oral Fumarate in RRMS (CONFIRM) study.
BG-12 is an investigational oral therapy, currently in late-stage clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS).
The CONFIRM clinical trial is a global randomised double-blind placebo-controlled dose-comparison study that enrolled 1,430 people with RRMS to evaluate the efficacy and safety of two dose regimens of BG-12, 240mg BID and 240mg TID, as well as a reference comparator of glatiramer acetate (GA, 20mg subcutaneous daily injection) versus placebo.
In the study, BG-12 met the primary endpoint by considerably reducing annualised relapse rate (ARR) by 44% for BID and by 51% for TID and secondary endpoint by reducing the proportion of patients who relapsed at two years by 34% for BID and by 45% for TID compared to placebo.
Additionally, BG-12 achieved magnetic resonance imaging (MRI) endpoints in a cohort of patients, demonstrating considerable reductions in new brain lesion counts, which were sustained throughout the study.
The study data 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 and by 24% for TID compared to 7% with GA.
Biogen Idec Research and Development executive vice president Douglas Williams said results from CONFIRM complement the profile seen for BG-12 throughout the clinical development programme, which now includes data sets from two global, placebo-controlled Phase 3 pivotal studies with more than 2,600 MS patients.
Cleveland Clinic, US, Mellen Center for Multiple Sclerosis medical director and principal investigator of the trial Robert Fox said the encouraging efficacy and safety results from the CONFIRM study suggested that BG-12 may be a positive addition to the current MS treatment paradigm.
Earlier this year, the company had submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for marketing approval of BG-12 in the US and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for review in the European Union.
Image: Demyelination by MS. The CD68 coloured tissue shows several macrophages in the area of the lesion. Photo: Marvin 101.