PETAH TIKVA (dpa-AFX) - Teva Pharmaceutical Industries Ltd. (TEVA) and Active Biotech (ACTI.ST) Wednesday announced enrollment of the first patient in the CONCERTO study - the third Phase III placebo-controlled study designed to evaluate the efficacy, safety and tolerability of once-daily oral laquinimod in patients with relapsing-remitting multiple sclerosis or RRMS.
Laquinimod is an oral, once-daily CNS-active immunomodulator with a novel mechanism of action. It is being developed for the treatment of MS. The global Phase III clinical development program evaluating oral laquinimod in MS includes two pivotal studies - ALLEGRO and BRAVO.
The primary outcome measure of CONCERTO will be confirmed disability progression as measured by the Expanded Disability Status Scale.
The multinational, randomized, double blind placebo-controlled study will aim to enroll 1,800 patients at more than 300 sites globally. 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.
CONCERTO principal investigator Dr. Timothy Vollmer said, '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.'
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