Teva Neuroscience, Inc. and Active Biotech
- Oral medication; 0.6 mg taken once daily. It has been granted Fast Track status by the FDA.
- Laquinimod is being studied in RRMS. Although its exact mechanisms of action are unknown, it is an immunomodulator, apparently via its effects on cytokines and interleukins. It also appears to reduce white blood cell penetration of the CNS. In addition to its immunomodulatory actions, laquinimod increases levels of the brain-derived neurotrophic factor (BDNF). BDNF may contribute to neuroprotection in MS patients.
- A 36-week Phase II trial showed a 40-percent reduction in disease activity as measured by MRI, a trend toward reduction in annual relapse rates, and a delay in the time to first relapse. The drug was well tolerated.
- The ongoing placebo-controlled ALLEGRO study of 1,000 individuals will determine the efficacy of daily oral treatment with laquinimod in RRMS versus placebo. Its outcome measures include the number of confirmed relapses, the accumulation of physical disability, and MRI changes during the two-year study period. The study began in February 2007 and is scheduled for completion in February 2011.
- Enrollment has been completed for the BRAVO Phase III pivotal trial with 1,200 patients. BRAVO is a global, 24-month, double-blind study designed to evaluate the efficacy, safety, and tolerability versus placebo. It will also provide risk-benefit data for laquinimod versus Avonex. Outcome measures are relapse rate, the accumulation of disability, and disease activity on MRI. The study is scheduled for completion in June 2011. A second large global phase III trial is now beginning enrollment.