Phase III study of BG-12 in relapsing-remitting multiple sclerosis sparks excitement

Citeline, an Informa business unit, and the world's leading research authority on pharmaceutical clinical trials recently reviewed results presented at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS), a major multiple sclerosis conference which was held October 19-22, 2011 in Amsterdam.  

Phase III study of oral BG-12 in relapsing-remitting multiple sclerosis sparked excitement as the details of the Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS (DEFINE) trial were presented at the meeting, quickly boosting BG-12 to stardom status.

The DEFINE study, supported by Biogen-Idec, showed that 240 mg of BG-12, administered either twice (BID) or three times a day (TID), significantly reduced the proportion of patients who relapsed by 49 percent and 50 percent, respectively, at two years compared with placebo.  It is believed that BG-12 has dual anti-inflammatory and neuroprotective effects via the Nrf2 pathway.  Citeline's analyst Dr. Heidi Chen shared the latest buzz about BG-12 as a promising therapeutic for relapsing-remitting multiple sclerosis patients, "BG-12 offers an attractive package with its distinct and novel mechanism of action, which really adds a sweet edge to the competition."  

BG-12 received Fast Track designation from the U.S. Food and Drug Administration (FDA) in 2008.  Since the initial results of the DEFINE study were announced in April 2011, BG-12 continues to be a strong contender with its encouraging safety profile.  Dr. Heidi Chen from Citeline noted, "The combined portfolio of efficacy and a robust safety data, BG-12 could become a first line of defense in the treatment of RRMS."  The top-line results of DEFINE trial were replicated in the second pivotal Phase III trial CONFIRM, which significantly reduced annualized relapse rate (ARR) by 44 percent for BID (p< 0.0001) and by 51 percent for TID (p< 0.0001) versus placebo at two years.  Biogen-Idec announced the results of the CONFIRM trial only days after it presented detailed data of the DEFINE study at the 5th Joint Triennial Congress of the European and Americas Committees on Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in October 2011.   In fact, results from the CONFIRM study showed that BG-12 beats Teva's Copaxone, which reduced the ARR by only 29 percent (p< 0.02) compared with placebo at two years.

With two robust and positive pivotal clinical trials that exposed BG-12 to over 2,600 patients, the drug is well positioned as a top MS therapy of choice and a formidable competitor to Gilenya from Novartis, which gained FDA approval in September 2010.