Teva Pharmaceutical Industries Ltd. (TEVA) and Active Biotech reported Monday that a 36-week phase IIb extension study of Laquinimod in the treatment of relapsing remitting multiple sclerosis or RRMS demonstrated sustained positive benefit-risk profile.
Laquinimod is an investigational, once-daily oral immunomodulator being developed as a disease-modifying treatment for RRMS. Laquinimod is currently in Phase II development for Crohn's disease and Lupus, and is being studied in other autoimmune diseases. The investigational Laquinimod has received Fast Track designation from the U.S. Food and Drug Administration or FDA in February 2009.
In the extension study, patients originally randomized to placebo in the LAQ/5062 phase II study were re-randomized to either 0.3 mg or 0.6 mg, while patients originally randomized to active treatment continued with the same treatment assignment for an additional 36 weeks.
Teva reported that the patients who switched from placebo to Laquinimod showed a 52% reduction in the mean number of gadolinium-enhancing-GdE T1 lesions, a marker of disease activity. Patients initially randomized to 0.6 mg laquinimod showed a maintenance of reduced MRI activity.
Two hundred thirty-nine or 93% patients completed the extension phase of the multinational double-blind study and 222 or 87.1% had a final scan.
The proportion of GdE-free patients for those who switched from placebo increased from a baseline of 31% to 47% at the end of the extension phase. No new adverse events emerged during the extension study. Further, incidence rate of liver enzymes elevation observed in the core study decreased in the extension phase.
Teva said treatment with laquinimod was associated with a sustained reduction in relapse rate, no evidence of immunosuppression and good safety and tolerability profile.
Further, the company said, it looks forward to the results of the Phase III Allegro and Bravo studies on multiple sclerosis patients in 2011.
Active Biotech developed laquinimod and licensed it to Teva in June 2004. A Phase IIb study in 306 patients demonstrated significantly reduced MRI disease activity, by 60% versus placebo in relapsing remitting multiple sclerosis or RRMS patients.
TEVA is currently trading on the NASDAQ at $54.08, up $0.60 or 1.12%. Over the past year, the stock traded in a range of $46.99 - $64.95.
by RTT Staff Writer
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