One of the more intriguing experimental drugs for multiple sclerosis has just entered its first clinical trial. Cambridge, MA-based Biogen Idec (NASDAQ: BIIB) has now started what it believes to be the first-ever clinical trial of a drug with the potential to regenerate the fatty protective coating around nerves that gets damaged in people with multiple sclerosis.
Biogen plans to enroll 64 healthy volunteers in the Netherlands, who will get a single intravenous infusion of what’s being called BIIB-033, says company spokeswoman Tracy Vineis. The study, listed in detail here on clinicaltrials.gov, will look at whether the targeted antibody drug is safe and well-tolerated, along with measurements on how long it stays in the body. Results from this initial test should be available in 2011, Vineis says.
This trial is more interesting than the usual run-of-the-mill study. That’s because the current standard treatments for MS, a neurodegenerative disease, are only thought to slow down the progressive damage of the disease. Biogen scientists hope to change the paradigm of treatment with this newer drug, by developing an antibody that blocks a new target called the Lingo-1 protein. By hitting this marker on cells, the company hopes that it will restore the body’s natural process of building a fatty protective layer around nerve fibers, known as myelin. As I described in an in-depth feature on the program back in August 2008, this is sort of like putting rubber coating back around electrical wires so they don’t short-circuit.
“As far as we know, this is the first drug in clinical trials with the potential to repair MS damage,” Vineis says. “We’re very excited about it.”
It’s too early to say what Biogen’s ultimate strategy will be for the best use of the anti-Lingo1 antibody. But it’s possible that patients could start on existing drugs that stop the progressive nerve damage, and then switch to the new drug that regenerates the protective myelin coating. If Biogen can prove the drug is safe, and does what it is supposed to do scientifically, this could be a very big deal in a few years for the 400,000 or so people in the U.S. with multiple sclerosis.
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