TEVA TO INITIATE THIRD PHASE III TRIAL OF ORAL LAQUINIMOD FOR THE TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS
The clinical trial protocol has been granted a Special Protocol Assessment
agreement by the Food and Drug Administration
Jerusalem, Israel and Lund, Sweden, August 8, 2012 - Teva Pharmaceutical
Industries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI)
provided today an update on the clinical development program of once-daily oral
laquinimod for the treatment of relapsing-remitting multiple sclerosis (RRMS).
The companies are to initiate a third Phase III study of laquinimod, following
the written agreement reached with the U.S. Food and Drug Administration (FDA)
on the Special Protocol Assessment (SPA).
The third Phase III laquinimod trial CONCERTO will evaluate two doses of the
investigational product (0.6mg and 1.2mg) in approximately 1,800 patients for up
to 24 months. The primary outcome measure will be confirmed disability
progression as measured by the Expanded Disability Status Scale (EDSS).
"The results achieved in the previous Phase III trials of laquinimod support the
clinical utility of this compound as a unique treatment option for multiple
sclerosis, " said Dr. Michael Hayden, President of Global R&D and Chief
Scientific Officer, Teva Pharmaceutical Industries Ltd. "We are encouraged by
the FDA´s agreement on the trial design and planned analysis, and look forward
to further developing laquinimod as a potential treatment option for RRMS
patients."
ABOUT LAQUINIMOD
Laquinimod is an oral, once-daily CNS-active immunomodulator with a novel
mechanism of action being developed for the treatment of MS. In animal models
laquinimod crosses the blood brain barrier to potentially have a direct effect
on resident CNS inflammation and neurodegeneration. The global Phase III
clinical development program evaluating oral laquinimod in MS includes two
pivotal studies, ALLEGRO and BRAVO.
In addition to the MS clinical studies, laquinimod is currently in Phase II of
development for Crohn´s disease and Lupus.
ABOUT SPECIAL PROTOCOL ASSESMENT (SPA)
A SPA is a written agreement between the FDA (Food and Drug Administration) and
a drug sponsor intended to confirm that the clinical trial protocol is adequate
to meet current scientific and regulatory requirements for a potential new drug
application.
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ABOUT MULTIPLE SCLEROSIS
MS is the leading cause of neurological disability in young adults. It is
estimated that more than 400,000 people in the United States are affected by the
disease and that two million people may be affected worldwide. Multiple
sclerosis is a degenerative disease of the central nervous system in which