Active Biotech’s MS pill reduces relapse rate
Lund/Jerusalem – Active Biotech’s oral small molecule immunomodulator laquinimod (ABR-215062) has reached the primary endpoint of statistically significant reduction in annualized relapse rate compared to placebo, according to initial results of a phase III study including 1,106 patients with relapsing-remitting multiple sclerosis. The successor of Active Biotech's failed experimental immunomodulator linomide, which is co-developed with Israeli generics giant Teva Pharmaceutical Industries Ltd., is thought to fully inhibit infiltration of the CNS by immune cells. On a once-daily 0.6 mg dose also other endpoints were reached, such as significant reduction in disability progression, as measured by Expanded Disability Severity Scale (EDSS), as well as safety endpoints. The overall frequencies of adverse events were comparable to those observed in the placebo group without deaths. Overall incidence of infections was similar between the two arms of the trial. Additional analyses of the ALLEGRO study data are ongoing, and detailed results will be presented in Q2/2011 said the companies. The second pivotal phase III study, BRAVO is still ongoing, with results anticipated in the third quarter of 2011. In September, Swiss Novartis AG's Gilenya gained US market approval as the first oral therapy for the disease. Previously, all multiple-sclerosis treatments were injected or given intravenously.