September 20, 2010
“The results from this extension study confirm the balanced efficacy, safety, and tolerability profile seen with laquinimod to date”
- Positive benefit-risk profile of laquinimod sustained in Phase II extension study
- 52 percent reduction (p=0.0006) in mean number of gadolinium-enhancing (GdE) T1 lesions
- Results from pivotal Phase III studies, ALLEGRO and BRAVO, anticipated in 2011
JERUSALEM—Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced results from a 36-week active extension study evaluating two doses of laquinimod, an investigational, once-daily oral immunomodulator, for the treatment of relapsing remitting multiple sclerosis (RRMS). The double-blind, multinational study demonstrated the sustained positive benefit-risk profile of laquinimod, which was shown to reduce Gd-enhancing (GdE) T1 lesions, while maintaining a good safety profile. These findings were published online by the journal Multiple Sclerosis.
Patients originally randomized to placebo in the core Phase II study, LAQ/5062, (published in The Lancet*) were re-randomized to either 0.3 mg or 0.6 mg laquinimod for the extension study, while patients originally randomized to active treatment continued with the same treatment assignment for an additional 36 weeks. Patients switching from placebo to an active treatment of laquinimod showed a 52 percent reduction in the mean number of GdE lesions (p=0.0006), a marker of disease activity. In patients initially randomized to 0.6 mg laquinimod, the reduction of MRI activity was maintained. Additionally, treatment with laquinimod was associated with a sustained reduction in relapse rate, no evidence of immunosuppression and good safety and tolerability profile.
“The results from this extension study confirm the balanced efficacy, safety, and tolerability profile seen with laquinimod to date,” explains Giancarlo Comi, M.D., the lead study author and the Director of the Department of Neurology and Institute of Experimental Neurology at the University Vite Salute, San Raffaele. “We look forward to the results of the Phase III ALLEGRO and BRAVO studies in 2011, and the potential of this novel agent to address the current unmet need for MS patients seeking a safe, effective and well tolerated oral therapy.”
Laquinimod received Fast Track designation from the U.S. Food and Drug Administration (FDA) in February 2009. Two global Phase III clinical studies, ALLEGRO and BRAVO are currently ongoing, with results anticipated during Q1 and Q3 2011, respectively.
* Comi G. et al. (2008). Effect of laquinimod on MRI-monitored disease activity in patients with relapsing remitting multiple sclerosis: a multicentre, randomized, double-blind, placebo-controlled phase IIb study. The Lancet; 371:2085-92.
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