Teva Pharmaceutical Industries Ltd. and Active Biotech announced today results from the two-year Phase III ALLEGRO study of laquinimod, an oral, once-daily, investigational immunomodulator for the treatment of relapsing forms of multiple sclerosis (MS). These data will be presented as late-breaking research at the Annual Meeting of the American Academy of Neurology (AAN).
In the ALLEGRO study, laquinimod showed a statistically significant 23 percent reduction in annualized relapse rate (p=0.0024), the primary endpoint, along with a significant 36 percent reduction in the risk of confirmed disability progression, as measured by Expanded Disability Status Scale (EDSS) (p=0.0122). Treatment with laquinimod was also associated with a significant reduction in brain tissue loss, as measured by a 33 percent reduction in progression of brain atrophy (p<0.0001).
“The ALLEGRO study results are exciting, as they suggest that oral laquinimod is a novel therapeutic option that safely slows MS disease activity and progression,” said Principal Investigator, Professor Giancarlo Comi, Director of the Department of Neurology and Institute of Experimental Neurology at the University Vite Salute, San Raffaele, Italy. “Additional pre-clinical data presented at this meeting suggest that oral laquinimod exerts a novel and protective mechanism of action within the central nervous system to significantly reduce the main neurological damage of the disease.”
Laquinimod was safe and well-tolerated without immunosuppressive effects. The overall frequencies of adverse events, including incidence of infections, were comparable to those observed in the placebo group. The most commonly reported adverse events were headaches, nasopharyngitis and back pain. The incidence of liver enzyme elevation was higher in laquinimod treated patients; however, these elevations were transient, asymptomatic and reversible. No deaths were reported in laquinimod-treated patients.
Continue Reading
.
***************************************************************************************
.
.