Teva Completes Enrollment In Second Oral Laquinimod Phase-III Trial

Published: 25-Jun-2009

Clinical trial designed to evaluate efficacy, safety and tolerability of laquinimod versus placebo

Teva and Active Biotech have announced the completion of patient enrollment for the second pivotal phase-III clinical trial, BRAVO. It is intended to evaluate oral once-daily immunomodulating compound, laquinimod, for the treatment of relapsing-remitting multiple sclerosis (RRMS).

BRAVO is a global clinical trial designed to evaluate the efficacy, safety and tolerability of laquinimod versus placebo, and to provide risk-benefit data for laquinimod versus a currently available injectable Avonex, the company said.

The BRAVO study completed patient enrollment in June, recruiting more than 1,200 patients at 156 sites in the US, Europe, Israel and South Africa.

Moshe Manor, Vice President of Global Branded Products at Teva, said: “Teva and Active Biotech are encouraged by the potential of laquinimod to address patients' unmet need for an oral immunomodulating MS therapy that provides efficacy while maintaining safety.”

“We look forward to continuing our clinical Phase III program of laquinimod, and hope it will offer enhanced quality of health for RRMS patients,” he added.

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