Teva Pharmaceutical Industries Ltd. and Active Biotech have provided an update on the clinical development programme 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 US 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 scentific 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.”
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 programme 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.
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
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 inflammation and axonal damage and loss result in the development of progressive disability.
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients.
Active Biotech AB is a biotechnology company with focus on autoimmune/inflammatory diseases and cancer.