Biotech company Biogen Idec (NASDAQ:BIIB) said Monday that it has achieved its main goal in a phase 3 study for oral drug BG-12, designed to treat patients with relapsing-remitting multiple sclerosis (RRMS).
RRMS is characterised by relapses, also known as exacerbations, during which time new MS symptoms can appear and old ones can resurface or worsen. The relapses are followed by periods of remission, during which time the person fully or partially recovers.
Results from the first of two phase 3 studies showed that BG-12, when administered twice or three times daily, significantly reduced the proportion of patients with RRMS who relapsed at two years, compared with placebo.
Both doses of BG-12 tested also met all of the secondary goals of the study, including providing a "statistically significant" reduction in annualized relapse rate and in the rate of disability progression.
"We are very pleased with these data and believe that BG-12 has the potential to offer MS patients a highly effective oral treatment option with a strong safety profile," said the company's executive vice president of research and development, Douglas Williams.
The trial, called Define, was a global placebo-controlled study that was designed to test the safety and efficacy of the drug in more than 1,200 patients with RRMS. BG-12 works by reducing the entry into and the action of inflammatory cells on the central nervous system (CNS), as well as by potentially protecting CNS cells from death.
Further tests of the Define study are ongoing, and the company anticipates presenting detailed data at a future medical conference. Another phase 3 RRMS clinical trial, called Confirm, is also underway, with results expected in the second half of this year.
Biogen Idec's shares were up nearly 7% in pre-market trading on Monday.
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