Laquinimod (also known as Nerventra or ABR-215062) is an investigational active immunomodulator of the central nervous system that is currently being developed for treatment of relapsing-remitting multiple sclerosis (RRMS), primary progressive multiple sclerosis (PPMS), and Huntington’s disease. How laquinimod works is not quite understood, but it is thought to stop immune cells from entering the brain and spinal cord, which could lead to less myelin damage. Early studies suggest that laquinimod may have an anti-inflammatory action and an ability to protect nerve structure and function.

Studies of laquinimod

Laquinimod showed promising results in two Phase 3 studies — ALLEGRO (NCT00509145) and BRAVO (NCT00605215).

The BRAVO study compared the effects of 0.6 mg of laquinimod with interferon beta-1a (Avonex) and a placebo. It did not find a statistically significant reduction in relapse rates in participants compared to the placebo group, but it significantly reduced the rates of brain shrinkage and disability progression. The study has been extended to evaluate the long-term safety, tolerability, and effect on disease in people with RRMS.

ALLEGRO was an earlier two-year Phase 3 study. It showed that 0.6 mg daily of laquinimod reduced relapse rates by 23% and disability progression by 36% compared to placebo.

Laquinimod is currently being tested in another Phase 3 study called CONCERTO (NCT01707992) in people with RRMS and a Phase 2 study called ARPEGGIO  (NCT02284568) for people with PPMS.

The CONCERTO study aims to measure the time to three-month confirmed-disability progression as measured by the Expanded Disability Status Scale (EDSS). Results are expected during the first half of 2017.

The ARPEGGIO study aims to measure brain atrophy. Results are expected to come in the second half of 2017.

In January 2016, the Data Monitoring Committee (DMC) called for the immediate discontinuation of higher doses of laquinimod in the two ongoing studies after cardiovascular events (none fatal) were reported in eight participants (seven in the CONCERTO study and one in the ARPEGGIO study). Teva and Active Biotech discontinued the higher doses immediately in both trials but encouraged participants to continue follow ups.

Although Teva and Active Biotech submitted an application for licensing the product in Europe for RRMS and were refused, they maintain that the product has potential to treat multiple sclerosis.

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