Teva Pharmaceutical Industries and Active Biotech have announced that patients are being enrolled for the Bravo Phase III pivotal trial.
Bravo is a global, 24-month, double-blind study designed to evaluate the efficacy, safety and tolerability of the oral compound laquinimod versus placebo, and to provide risk-benefit data for laquinimod versus a currently available injectable treatment, Avonex.
The Bravo trial, which was initiated in April, 2008, aims to enroll approximately 1,200 patients with relapsing-remitting multiple sclerosis (RRMS). The globally conducted study will include centers in the US, Europe, and Israel. A second global Phase III trial of laquinimod including 1,000 patients, Allegro, is also ongoing and recruiting patients globally.
Timothy Vollmer, principal investigator of the Bravo study, said:
"All currently approved multiple sclerosis (MS) treatments are administered via injection or infusion. The ability to provide a safe and effective oral treatment option would be a significant advancement for the treatment of MS.
"Additionally, the mode of action for laquinimod is unlike any other MS compound, existing or experimental. We are hopeful that this research will expand our abilities to combat the disease through novel targeting."
Pharmaceutical Business Review
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