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|April 23, 2015 2:01 p.m.|
|Teva and Active Biotech Announce First Patient Enrolled in Phase II Study Evaluating Laquinimod for Primary Progressive MS|
Phase II ARPEGGIO study design to be presented at the 67th
PPMS affects approximately 15 percent of all MS patients and is characterized by the worsening of neurologic function without distinct relapses (also called attacks or exacerbations). Unlike patients with relapsing-remitting MS (RRMS), those with PPMS tend to have more lesions in the spinal cord than in the brain and these brain lesions usually contain fewer inflammatory cells. In addition, all studies evaluating RRMS treatments in patients with PPMS have failed to prove effective for this condition.
“Laquinimod may represent an opportunity to help meet the challenge of
ARPEGGIO is a multinational, multicenter, randomized, double-blind,
parallel-group, placebo-controlled study of once-daily, oral laquinimod
(0.6mg or 1.5mg/day) in patients with PPMS. The study’s primary endpoint
is percent brain volume change (PBVC) through MRI analysis. The trial
will enroll approximately 375 patients in the U.S.,
Additional details on the study design will be presented at the AAN
Annual Meeting in
Laquinimod is a once-daily oral, investigational, CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of relapsing-remitting MS (RRMS), progressive MS and Huntington’s disease. The global, Phase III, clinical development program evaluating laquinimod in MS includes two completed pivotal studies, ALLEGRO and BRAVO (both 0.6mg/day). A third Phase III trial, CONCERTO, is currently ongoing and evaluating two doses of laquinimod (0.6mg and 1.2mg/day) in approximately 2,100 patients for up to 24 months. The primary outcome measure is time to three-month confirmed-disability progression as measured by the Expanded Disability Status Scale (EDSS).
In the ALLEGRO and BRAVO trials, adverse reactions observed included headache, abdominal pain, back and neck pain, appendicitis, and mild, asymptomatic laboratory abnormalities, including liver enzyme elevations, hematological changes and elevation of CRP or fibrinogen levels.
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increased government scrutiny in both the U.S. and
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Teva Pharmaceutical Industries Ltd.