Teva announces positive data from multiple sclerosis extension study

In relapsing-remitting multiple sclerosis patients who switched from placebo to laquinimod, 52% reduction in the mean number of GdE lesions was observed (p<0.0007). The reduction was significant for both patients switching to high-dose (p<0.009) and low-dose laquinimod (p<0.03). In addition, the proportion of patients who switched to active treatment from placebo, and remained enhancing lesion-free, increased from 31% to 47% (p<0.012), further reinforcing the efficacy of laquinimod on magnetic resonance imaging (MRI) measured disease activity. Patients initially treated with 0.6mg/day and 0.3mg/day during the double-blind trial remained on the same dose during the 36-week extension phase. An additional significant reduction in the mean number of GdE lesions was also observed in these patients (n=94, p=0.0062 and n=80, p=0.0013, respectively), a high proportion of which remained completely free of GdE lesions, demonstrating the sustained effect of laquinimod on MRI disease activity. These new data from the extension study built upon the initial 36-week, Phase IIb study results, which demonstrated that once-daily, oral 0.6mg laquinimod significantly reduced MRI disease activity by a median of 60%, compared to placebo, and was well tolerated. Teva is currently enrolling patients for Allegro and Bravo, two pivotal Phase III clinical trials of laquinimod. Giancarlo Comi, principal investigator of the study, said: "These latest data show the rapid onset and sustainability of laquinimod efficacy in multiple sclerosis patients. Just as exciting is the fact that, with increased number of patients exposed to laquinimod, we found no new risks or safety issues. This reinforces earlier results demonstrating the laquinimod safety profile."