Drug safely retards MS progression for many in two-year, 24-country Phase III trial

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“These exciting results confirm that laquinimod has a significant impact on progression of disability and disease activity, while maintaining a high safety profile.”

The orally-administered drug laquinimod reduced the number of relapses for people with multiple sclerosis (MS), in a large, long-term Phase III clinical study presented as breaking news at the annual meeting of the American Academy of Neurology in April.

The study involved 1,106 people with relapsing-remitting MS* in 24 countries. The participants received either a once-daily oral dose of 0.6 mg laquinimod or a matching placebo for two years. Eighty percent of those taking laquinimod and 77% of those taking the placebo finished the two-year study.

• Patients treated with laquinimod experienced a statistically significant [average] reduction of 23% in annual relapse rate, compared to patients treated with a placebo.

• Additionally, there was a [average] reduction of 36% in disability progression, as well as a 33% reduction in brain atrophy for those people treated with laquinimod.

“These exciting results confirm that laquinimod has a significant impact on progression of disability and disease activity, while maintaining a high safety profile,” said lead author Giancarlo Comi, MD, director of the Department of Neurology and Institute of Experimental Neurology at the Scientific Institute and University Vita-Salute San Raffaele in Milan, Italy.

“This may be attributed to the novel mechanism of action of laquinimod, which effectively and safely addressed both the acute inflammatory activity and the accumulation of irreversible tissue damage,” Dr. Comi adds. “This suggests a substantial future role for laquinimod in the treatment of MS.”

Laquinimod was safe and well tolerated. Overall frequencies of adverse events were low and comparable to those observed in the placebo group.

“The incidence of liver enzyme elevation was higher in laquinimod treated patients,” said Comi. “However, these elevations were temporary, reversible and did not lead to any signs of liver problems.”

[Note: Laquinimod’s mechanism of action in treatment of MS is not fully understood, but studies suggest it modulates immune system response from pro-inflammatory to anti-inflammatory by preventing the immune T cells which cause nerve damage in MS from crossing the blood brain barrier & entering the central nervous system. For more, see www.emsp.org.]

* See video briefly describing this and other forms of MS at the American Academy of Neurology website.

Source: American Academy of Neurology, Apr 11, 2011