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BG-12 - Fumerate                                                                                                                                                                                                                        

An oral version of the drug fumerate, the demonstration of its anti-inflammatory action suggests that it may be helpful by preventing or reducing the inflammation which contributes to damage in the brain and spinal cord. It is able to effect the immune system and there is evidence to support the development of BG-12 to treat a number of conditions involving T cells and inflammation.

BG-12 (Fumerate) is taken as a once a day tablet

A phase II study was designed to evaluate the safety and effectiveness of BG-12 in 257 people with relapsing remitting multiple sclerosis at sites in 10 countries across Europe. Participants received one of three different doses of BG-12 or placebo. The group treated with the higher dose had a 69 percent reduction in lesions compared to placebo. The results of the other doses of BG-12 treated groups showed no difference compared to placebo.

Biogen Idec is carrying out phase III clinical trials of BG-12 for relapsing remitting multiple sclerosis (RRMS). A determination of the efficacy and safety of oral fumarate in relapsing remitting multiple sclerosis (RRMS) and a comparator and an oral fumarate in relapsing remitting multiple sclerosis (RRMS) study will include more than 2,000 people with multiple sclerosis worldwide. These studies will be initiated in the U.S. in late 2008.

Both studies will evaluate the effect of BG-12 relapse rate, the progression of disability, and various MRI brain scan measures.

Side effects may occur                                                                                                                                                                                                               

 

BG-12 Data "Underwhelming," Neurologists Say                                                                                                                                                                          

Biogen's BG-12 is currently being studied in two Phase III trials, but a Phase IIb study showed the drug reduced the number of new gadolinium-enhancing lesions in patients with a tolerable safety profile.

Neurologists on the BIO panel, however, noted that the early data for BG-12 is "underwhelming," especially given that the trial evaluated dosing three times a day. "I don't think TID is a deal breaker, but it certainly doesn't make it attractive," Bennett said, citing patient compliance issues.

But Tullman pointed out that safety will trump dosing frequency. "If you are the only oral in town, we can deal with it," he said. A modestly effective oral therapy with a strong safety profile could become a first-line treatment option, with riskier, more efficacious drugs relegated to the second-line position, he added.

 

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