Teva Pharmaceutical Industries and Swedish partner Active Biotech are celebrating this morning after their experimental oral multiple sclerosis drug laquinimod impressed in late-stage trials.
The Israeli firm announced initial results from the two-year Phase III ALLEGRO study, which demonstrated that relapsing-remitting MS patients treated with 0.6mg daily oral laquinimod experienced a statistically significant reduction in annualised relapse rate compared to placebo, the primary endpoint. Treatment with the drug also resulted in significant reduction in disability progression, and demonstrated a favourable safety and tolerability profile.
Teva noted that detailed results will be submitted at a leading scientific conference during the first half of 2011. The company quoted lead investigator Giancarlo Comi, of the University Vite Salute, San Raffaele, Italy, as saying that laquinimod demonstrated a significant reduction in the progression of disability "which may be explained by its unique mechanism of action that includes neuroprotective properties". It may therefore be "a promising therapeutic option for the MS community", he added.
The market for oral MS treatments is set to grow especially after Novartis' pill Gilenya (fingolimod) got US approval in September, while Merck KGaA is hoping for good news from regulators on both sides of the Atlantic soon for Movectro (cladribine). As for laquinimod, a second Phase III study, BRAVO, is still ongoing with results anticipated in the third quarter of 2011.
In addition to the ongoing MS studies, laquinimod is currently in Phase II for Crohn's disease and lupus, and is being studied in other autoimmune diseases.