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|March 06, 2013|
|First Patient Enrolled in Third Phase III Study of Oral Laquinimod for Relapsing-Remitting Multiple Sclerosis|
CONCERTO Study Enrolling Patients Globally to Evaluate Impact of Laquinimod on Disability Progression
“Previous Phase III studies in more than 2,400 people with RRMS suggest
a unique profile of laquinimod, directly affecting the neurodegenerative
processes that lead to disability progression, the main concern in the
treatment of RRMS,” said CONCERTO principal investigator, Dr.
The multinational, randomized, double blind placebo-controlled study will aim to enroll approximately 1,800 patients at more than 300 sites globally (http://clinicaltrials.gov/show/NCT01707992). Along with the primary endpoint of time to confirmed disability progression, the study will also examine the impact of laquinimod on endpoints such as percent change in brain volume and other clinical and MRI markers of disease activity.
“For nearly 30 years, Teva has been focused on improving the lives of
people with multiple sclerosis by delivering innovative treatment
options that address this complex disease,” said Dr.
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 clinical development for Crohn's disease and Lupus.
CONCERTO is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by an active treatment phase, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod 0.6 mg/day or 1.2 mg/day in subjects with RRMS. This third Phase III laquinimod study will evaluate laquinimod in approximately 1,800 patients for up to 24 months, after which patients will continue to an active treatment period with laquinimod for an additional 24 months. The primary outcome measure will be time to confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS). The study will also examine the impact of laquinimod on endpoints such as percent change in brain volume, as well as other clinical and MRI markers of disease activity.
ABOUT MULTIPLE SCLEROSIS
MS is the leading cause of neurological disability in young adults. It
is estimated that more than 400,000 people in
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competition for our innovative products, especially Copaxone® (including
competition from innovative orally-administered alternatives, as well as
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result of increased governmental pricing pressures), competition for our
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results through our innovative R&D efforts, the effectiveness of our
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opportunities to obtain U.S. market exclusivity for significant new
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integrate acquisitions, the effects of increased leverage as a result of
the acquisition of Cephalon, the extent to which any manufacturing or
quality control problems damage our reputation for high quality
production and require costly remediation, our potential exposure to
product liability claims to the extent not covered by insurance,
increased government scrutiny in both the U.S. and
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Teva Pharmaceutical Industries Ltd.