Biogen Idec today announced enrollment of the first patient in a multicenter Phase II clinical trial designed to evaluate its investigational oral therapy BG-12 (dimethyl fumarate, tecfidera) in combination with commonly used first-line treatments in patients with relapsing-remitting multiple sclerosis (RRMS). The trial, called EXPLORE, will evaluate the safety and tolerability of BG-12 when administered with beta interferons (IFNB) or glatiramer acetate (GA) to patients who continue to have evidence of disease activity despite receiving consistent monotherapy for at least a year ,
"An
ongoing treatment challenge in MS is that many patients continue to
experience disease activity despite being on therapy," said Alfred
Sandrock, M.D., Ph.D., Senior Vice President of Neurology Research and
Development at Biogen Idec. "The goal of the EXPLORE trial is to
evaluate whether BG-12 may be a safe and effective agent to use in
combination with other MS therapies, an important consideration for
patients for whom new treatment strategies are needed."
BG-12
is the first compound in trials for the treatment of MS that has been
shown to activate the Nrf2 transcriptional pathway. Experimentally, the
Nrf2 pathway has demonstrated neuroprotective and anti-inflammatory
properties. Activation of this pathway in MS patients may potentially
prevent further cell damage and tissue loss caused by the disease.
Preclinical studies have shown that activation of the Nrf2 pathway
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.
Data
from the Phase IIb study in RRMS, combined with experimental data
showing BG-12's ability to activate the Nrf2 pathway, continue to
support its evaluation as a monotherapy in two extensive ongoing Phase
III MS studies, DEFINE and CONFIRM, which are fully enrolled. These data
also support its further investigation as a combination therapy in
EXPLORE.
"The
MS community is eager for new treatment options for this debilitating
disease," said Robert Fox, M.D., Staff Neurologist and Medical Director
at the Cleveland Clinic Mellen Center for Multiple Sclerosis Treatment
and Research. "BG-12 may offer patients an additional treatment
strategy. Its potential to both reduce inflammation and promote
neuroprotection, its safety data to date, as well as its oral
administration, support this study of BG-12 as a possible combination
therapy for MS."
"The
EXPLORE trial is another demonstration of Biogen Idec's commitment to
MS," said Dr. Sandrock. "We have one of the most extensive MS pipelines
in the industry, with multiple programs that target pathways thought to
be critical in treating MS. This pipeline includes late-stage programs
such as BG-12, PEGylated interferon beta 1a, and daclizumab,
earlier-stage programs such as anti-LINGO, and several preclinical
programs."
