Teva and Active Biotech have completed patient enrollment for the second pivotal Phase III clinical trial, BRAVO, designed to evaluate efficacy, safety and tolerability of multiple sclerosis (MS) drug laquinimod.
The trials are intended to evaluate the 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 a placebo, and to provide risk-benefit data for laquinimod as compared to a currently available injectable Avonex.
Teva vice-president of global branded products Moshe Manor said that the companies 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 programme of laquinimod, and hope it will offer enhanced quality of health for RRMS patients,” Manor said.
The BRAVO study completed patient enrollment in June 2009, recruiting more than 1,200 patients at 156 sites in the US, Europe, Israel and South Africa.