Teva to begin new Laquinimod Phase III trial

The first patient has been enrolled for the third Phase III trial of the oral multiple sclerosis treatment.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and Active Biotech (Nasdaq OMX Nordic: ACTI) are to begin a new Phase III trial for oral multiple sclerosis treatment Laquinimod. The two companies today announced enrollment of the first patient in the CONCERTO study - the third Phase III placebo-controlled trial to evaluate the efficacy, safety and tolerability of once-daily oral Laquinimod in patients with relapsing-remitting multiple sclerosis (RRMS). The primary outcome measure of CONCERTO will be confirmed disability progression as measured by the Expanded Disability Status Scale (EDSS).

University of Colorado Denver, Medical Director of the Rocky Mountain Multiple Sclerosis Center Professor of Neurology and Co-Director of the RMMSC at Anschutz 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. We are currently enrolling patients in this third pivotal study to further examine the clinical benefits of Laquinimod on disability progression, the primary endpoint of the CONCERTO trial, and brain atrophy, at both the previously studied 0.6 mg dose, and now a higher 1.2 mg dose."

The multinational, randomized, double blind placebo-controlled study will aim to enroll 1,800 patients at more than 300 sites globally. 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.

Teva president of global R&D and chief scientific officer Dr. Michael Hayden said, "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. The CONCERTO study demonstrates our commitment to collaborating with MS communities worldwide to further develop Laquinimod and address unmet patient needs."

Published by Globes [online], Israel business news - www.globes-online.com - on March 6, 2013

© Copyright of Globes Publisher Itonut (1983) Ltd. 2013

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