Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) and Active Biotech (Nasdaq: OMX NORDIC: ACTI) today announced positive results in the open-label extension of the Phase III ALLEGRO trial of oral multiple sclerosis treatment Laquinimod.
The study assessed the progression of disability and safety of Laquinimod in early versus delayed-start relapsing-remitting multiple sclerosis (RRMS) patients. The study compared the effectiveness of Laquinimod in patients who received 36 months (early-start) versus those who received 24 months of Laquinimod treatment (delayed-start).
Of the 864 RRMS patients who participated in the original double-blind ALLEGRO trial, 97% participated in the open-label extension, and 87% completed one year of the open-label phase. Overall, during the entire conduct of the study (double blind and open label phase), early start patients were less likely to experience disease progression than those with a delayed start of Laquinimod (11.8% risk of confirmed disability progression versus 16.7%).
Teva president of global R&D and chief scientific officer Dr. Michael Hayden said, "The results of this longer-term study of Laquinimod suggest a robust benefit in terms of early treatment for RRMS and in potentially delaying disability, which is a primary goal of RRMS treatment. The development of Laquinimod’s clinical profile has been full of exciting revelations about the compound’s unique mechanism of action, and we were dually encouraged by the preclinical data which demonstrated a potential direct effect on neuro-regenerative processes."
The study also supported a favorable safety and tolerability profile of Laquinimod in RRMS patients. No new safety concerns arose during the open-label phase.
Published by Globes [online], Israel business news - www.globes-online.com - on March 21, 2013
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