Teva Pharmaceutical Industries and Active Biotech have enrolled the first patient in a multinational, multicentre, randomised, double-blind, parallel-group, placebo-controlled Phase III study of its oral, once-daily CNS-active immunomodulator, laquinimod, designed for the treatment of relapsing-remitting multiple sclerosis (RRMS).
The study, Concerto, will enrol 1,800 patients at more than 300 sites to evaluate the efficacy, safety and tolerability of two oral doses of laquinimod 0.6mg/day or 1.2mg/day, in subjects with RRMS.
This study will assess patients for up to 24 months, after which patients will continue an active treatment period with laquinimod for additional 24 months, according to the company.
The primary outcome measure will be time to confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS).
In addition, the study will 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.
Rocky Mountain Multiple Sclerosis Centre medical director, University of Colorado Denver neurology professor and study 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."
Teva Pharmaceutical Industries global R&D president and chief scientific officer Dr Michael Hayden said; "The CONCERTO study demonstrates our commitment to collaborating with MS communities worldwide to further develop laquinimod and address unmet patient needs."
Laquinimod is also currently in clinical development for Crohn’s disease and Lupus.
Image: Teva’s plant at Har Hotzvim, Jerusalem. Photo: Courtesy of Jacob.