New Hope for Multiple Sclerosis
Today, Teva Pharmaceutical Industries Ltd., and Active Biotech announced the presentation of a Phase II clinical and pre-clinical data which would collectively demonstrate that once-daily oral laquinimod modulates the pathological processes of multiple sclerosis to impact disease activity, disability progression, and brain volume loss. The data will be featured in over 20 scientific presentations and posters this week, premiering at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis, held in Amsterdam, the Netherlands.
Findings from the Phase III study, titled BRAVO, are being touted as late-breaking research. It showed that at 24 months, the primary endpoint of reduction in annualized relapse rates did not reach statistical significance. However, after applying the pre-specified sensitivity analysis to correct for meaningful imbalances in baseline characteristics between treatment groups, laquinimod significantly reduced ARR. It also demonstrated a notable reduction in the risk of disability progression, which was measured by the Expanded Disability Status Scale. A result for the safety and tolerability profile of laquinimod was a good result.
The first Phase III study in the laquinimod program was called ALLEGRO, and demonstrated that laquinimod had an effect on the rate of severe relapses. It showed a 38% reduction in the annualized rate of relapses that required hospitalization, and 27% reduction in patients who required intravenous steroids.
According to Professor Giancarlo Comi, Director of the Department of Neurology and the Institute of Experimental Neurology at the San Raffaele Scientific Institute, ýThe life-long, debilitating nature of multiple sclerosis and well recognized clinical variability, underscore the need for therapies that can slow disease progression and improve patient treatment experience.ý He continued, ýBoth the ALLEGRO and BRAVO studies provide consistent evidence of a clear impact of laquinimod on progression of disability and brain atrophy, measures of the neurodegenerative process of MS.ý
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