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Laquinimod, a Novel Oral Compound, Showed Significant Reduction in,Disease Activity in Patients with Relapsing-Remitting Multiple,Sclerosis (RRMS)

ly oral laquinimod, are very exciting for the MS community--both patients and researchers," said Shlomo Yanai, President and CEO of Teva Pharmaceutical Industries Ltd. "Teva will soon initiate Phase III studies to confirm oral laquinimod's therapeutic benefits, and we expect to begin enrollment of the trial later this year."

About the Study

Study participants were required to have experienced one or more relapses in the year prior to entry and at least one Gd-enhancing lesion at screening. The patients (n=306) in the study were randomized to receive placebo (n=102), 0.3 mg dose of laquinimod (n=98) or 0.6 mg dose of laquinimod (n=106). At entry, active treatment and placebo groups were comparable for demographic, clinical and MRI characteristics.

Patients were assessed clinically and by MRI scan at week -4, baseline, and monthly from weeks 12 to 36. The primary outcome of the study was the cumulative number of Gd-enhancing lesions at weeks 24, 28, 32 and 36. Secondary outcomes of the study included additional MRI metrics and confirmed relapse rate.

The laquinimod 0.6 mg dose showed a reduction compared with placebo in the cumulative number of enhancing lesions per scan in the last four scans (mean SD= 2.6 5.3 vs. 4.2 9.2, p = 0.0048); treatment with the 0.3 mg dose showed no significant difference. Significant differences in favor of the 0.6 mg dose were found for most examined secondary and exploratory MRI-based outcome measures. Trends favored the group receiving the 0.6 mg dose on measures of annual relapse rate (0.52 +/- 0.92 vs. placebo 0.77 +/- 1.25; p = 0.21), relapse-free subjects (70.8 percent vs. 62.7 percent; p = 0.33) and time to first relapse (p = 0.14).

Treatment with both 0.3 and 0.6 mg doses of laquinimod were well tolerated with only some transient and dose-dependent increases in liver enzymes.

About laquinimod

Laquinimod is a novel once-daily, orally administered immunomodulatory compound developed a
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