Abbott Laboratories and its Massachusetts biotech partner have launched a final-stage clinical trial of their experimental treatment for multiple sclerosis.
The first patient — out of 1,500 needed worldwide — was enrolled last month in the U.S. The drug, daclizumab, is being developed for monthly injection under the patient’s skin by North Chicago-based Abbott and Cambridge-based Biogen Idec.
The
trial is important because the drug industry is searching for new ways
to change the course of the debilitating autoimmune disease, rather than
merely treating the symptoms, as most products on the market do.
Multiple sclerosis is a common neurological disorder in which a
patient’s immune system starts to attack the central nervous system. It
affects an estimated 2.5 million people worldwide.
“Despite
significant advances in MS therapy, many patients continue to
experience disease activity,” said Dr. Ludwig Kappos, lead investigator
for the Abbott and Biogen-funded study and head of MS research at
University Hospital in Basel, Switzerland. “The MS community is eager
for new treatment approaches.”
Biogen
already has a well-known therapy on the market called Tysabri, proven
to be effective by slowing progression of the disease in most patients
studied and reducing MS flare-ups. That has helped the drug become a
blockbuster that will generate more than $1 billion in annual sales for
the first time this year.
But
Tysabri also has a rare but deadly side effect. It has been linked to
causing a fatal disease called progressive multifocal
leukoencephalopathy, or “PML.”
As
of June 7, Biogen said, 55 people have developed PML and 11 of them
have died out of about 68,000 people on Tysabri. The U.S. Food and Drug
Administration is closely monitoring Tysabri, but has maintained the
drug’s benefits outweigh its risks.
In
clinical trials so far with daclizumab, there are no known cases of
PML, according to Abbott and Biogen. The drug is a monoclonal antibody
that works by attaching itself to disease cells.
Biogen
said enrollment of MS patients in the final stage clinical trial will
be completed next year. Some analysts say daclizumab could be submitted
to the FDA in the next three to four years for possible approval.