Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today 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).
“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,” said Dr. Michael Hayden, President of Global R&D and Chief Scientific Officer for Teva Pharmaceutical Industries, Ltd. “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 neuroregenerative processes.”
The study also supports a favorable safety and tolerability profile of laquinimod in RRMS patients. No new safety concerns arose during the open-label phase.
Additionally, a preclinical study in animal models demonstrated the ability of laquinimod to increase the myelinated axons and mature oligodendrocytes in the brain. This data suggests laquinimod has potential restorative and anti-inflammatory properties.