The trial, called Explore, is expected to evaluate the safety and tolerability of BG-12 when administered with beta interferons (IFNß) or glatiramer acetate (GA) to patients who continue to have evidence of disease activity despite receiving consistent monotherapy for at least a year. Efficacy endpoints will also be assessed in a subset of patients.
Biogen Idec claimed that 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.
According to Biogen Idec, the 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.
Alfred Sandrock, senior vice president of neurology research and development at Biogen Idec, said: “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.
“The Explore trial is another demonstration of Biogen Idec’s commitment to MS. 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.”