Early start/Late start laquinimod (Teva) in ALLERGO extension trial for MS
Teva Pharmaceutical Industries Ltd. and Active Biotech have announced top-line results from the open-label extension of the Phase III ALLEGRO study that assessed the progression of disability and safety of oral 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). Laquinimod is an oral, once daily, investigational drug in Phase III studies for RRMS. 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 vs 16.7%, HR = 0.62, p < 0.0038).