Teva Pharmaceutical Industries and Active Biotech have reported positive data from three-year Phase III study of oral laquinimod conducted in relapsing-remitting multiple sclerosis (RRMS) patients.
Early treatment with laquinimod demonstrated a significant reduction in risk of disability progression, compared to delayed treatment, in the open-label study.
Teva Pharmaceutical Industries chief scientific officer and global R&D president Dr Michael Hayden said the laquinimod study results suggest benefits of early treatment for RRMS and the potential to delay disability.
"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," Hayden said.
The effectiveness of laquinimod in patients who received 36 months (early-start) against those who received 24 months of laquinimod treatment (delayed-start) was compared in the double-blind study.
97% of the 864 RRMS patients took part in the open-label extension and 87% completed one year of the open-label phase.
Laquinimod also demonstrated a favourable safety and tolerability profile in RRMS patients without any new safety concerns.
Potential restorative and anti-inflammatory properties of laquinimod were also established in a preclinical study in animal models.