Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) 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).
“We are very enthusiastic about the results of the ALLEGRO study, which demonstrated that laquinimod significantly slows the progression of disability, the primary goal of MS treatment. Given the efficacy, safety and tolerability data to date, laquinimod may present a very promising treatment option to the MS community”
In the ALLEGRO study, laquinimod showed a statistically significant 23 percent reduction in annualized relapse rate.
"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.
The positive ALLEGRO results are supported by new pre-clinical data, also presented at the AAN meeting, that further establish the mechanism of action (MOA) of laquinimod, which led to a reduction in axonal damage, the main determinant of permanent clinical disability in MS. Data from the cuprizone model, designed to investigate the effect on neurodegeneration, independent of inflammation, demonstrated that laquinimod reduced demyelination and axonal damage while preserving more myelin-producing cells. This unique effect suggests a direct decrease in nerve damage in the central nervous system (CNS). Additionally, laquinimod was shown to modulate the brain-derived neurotrophic factor (BDNF) pathway, a key factor in maintaining axonal integrity.
"We are very enthusiastic about the results of the ALLEGRO study, which demonstrated that laquinimod significantly slows the progression of disability, the primary goal of MS treatment. Given the efficacy, safety and tolerability data to date, laquinimod may present a very promising treatment option to the MS community," said Professor Yitzhak Peterburg, Teva's Group Vice President, Global Branded Products.
The second laquinimod Phase III study, BRAVO, is currently ongoing with results anticipated in the third quarter of 2011. Regulatory submissions are planned in the U.S. and the EU following the availability of the BRAVO results.
SOURCE Teva Pharmaceutical Industries Ltd.