Biogen Idec (NASDAQ: BIIB) today announced that its oral compound BG-12 (dimethyl fumarate) achieved key milestones in clinical trials for multiple sclerosis (MS) and rheumatoid arthritis (RA). In recent months, the last patient was enrolled in the CONFIRM trial, the second of two Phase III trials designed to evaluate the efficacy and safety of BG-12 as a monotherapy in patients with relapsing-remitting multiple sclerosis (RRMS). Both the DEFINE and CONFIRM Phase III trials are now fully enrolled and will evaluate the effect of BG-12 on clinical relapse, disability progression, various MRI measures of disease activity, and safety.
The last patient was also enrolled in a Phase II study to evaluate the safety, tolerability and efficacy of BG-12 in combination with methotrexate in subjects with active RA who had an inadequate response to conventional disease-modifying antirheumatic drug (DMARD) therapy.
"There is significant unmet need in both the MS and RA communities for additional treatment options," said Kate Dawson, M.D., senior director, Medical Research, Biogen Idec. "The Phase IIb study of oral BG-12 in patients with MS showed promising MRI results regarding the compound's ability to reduce inflammation and its potential for neuroprotection. We look forward to results from the DEFINE and CONFIRM Phase III MS studies, as well as the proof-of-concept trial in RA."
BG-12 has been shown to activate the Nrf2 transcriptional pathway, which pre-clinical studies have shown defends against oxidative-stress induced neuronal death, protects the blood-brain barrier and supports maintenance of myelin integrity in the central nervous system. Central nervous system inflammation and damage may trigger the symptoms common in RRMS such as fatigue, cognitive deterioration and physical disability. Because of BG-12's unique effect on the Nrf2 pathway and its oral delivery, BG-12 is also being considered for future MS combination therapy studies.
Additionally, as an oral compound, BG-12 holds promise for patients with RA. Its combination of anti-inflammatory and potential cytoprotective properties support the compound's evaluation in RA.
BG-12 is an oral formulation of dimethyl fumarate. Fumaderm-, a therapeutic for the treatment of psoriasis in Germany, includes dimethyl fumarate as one of the active ingredients. Fumaderm has more than 14 years of post-marketing experience and approximately 100,000 patient years of use.