Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Active Biotech (NASDAQ OMX NORDIC:ACTI) announced today the presentation of additional analyses of the Phase III ALLEGRO and BRAVO studies supporting the hypothesis that once-daily, oral laquinimod may have an effect on both inflammation and the broader underlying mechanisms associated with disease progression in relapsing-remitting multiple sclerosis. Various new laquinimod data will be featured in 16 scientific posters and presentations at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark, October 2-5, 2013.
"Continued analysis of the ALLEGRO and BRAVO Phase III studies demonstrates that the trend of efficacy results was maintained in the analysis of data pooled from the two studies, and is consistent with the proposed mechanism of action for laquinimod," said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries Ltd. "Teva remains committed to the laquinimod clinical development program in MS and in other diseases characterized by a neurodegenerative pathology, and to addressing the needs of these patients worldwide.”
Results from a post-hoc subgroup analysis of pooled data from the Phase III double-blind ALLEGRO and BRAVO studies showed there were some patients who experienced disease progression without experiencing a relapse during the studies. Regardless of treatment arm and despite relapse status, 12 percent of patients studied experienced disability progression after two years; of those patients who progressed, approximately one-third did not experience a relapse. Results specific to treatment with laquinimod showed that both relapsing and relapse-free patients treated with laquinimod experienced less disease progression than those treated with placebo. Specifically, 19 percent of relapsing patients on laquinimod progressed compared to 22 percent on placebo and 4.8 percent of relapse-free patients on laquinimod progressed compared to 7.6 percent on placebo. Overall, laquinimod reduced disability progression by 26.7 percent in relapsing patients (P=0.058) and 38.9 percent in relapse-free patients (P=0.036) compared to placebo.