Teva Pharmaceutical and Active Biotech announced top-line results from an open-label extension of the Phase 3 ALLEGRO study, which assessed the progression of disability and safety of oral laquinimod in early vs. delayed-start relapsing remitting multiple sclerosis (RRMS) patients. Laquinimod is an oral, once-daily CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of MS.
The study compared the effectiveness of laquinimod in patients who received 36 months (early-start) vs. those who received 24 months of laquinimod treatment (delayed-start). Out of the 864 RRMS patients who participated in the original double-blind ALLEGRO trial, 97% enrolled in the open-label extension and 87% completed one year of the open-label phase.
During the entire duration 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 vs. 16.7%, HR = 0.62, P< 0.0038).