Teva Pharmaceutical Industries Ltd. and Active Biotech announced the first patient has been enrolled in the study A Randomized Placebo-controlled Trial Evaluating Laquinimod in PPMS, Gauging Gradations In MRI and Clinical Outcomes (ARPEGGIO), a phase II study to evaluate laquinimod, an investigational, oral, immune modulator, for the treatment of primary progressive multiple sclerosis (PPMS). Currently there are no approved treatments for PPMS, representing a condition with a high unmet need.

PPMS affects approximately 15 per cent 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 PPMS," said Michael Hayden, M.D., Ph.D., president of global R&D and chief scientific officer at Teva. "The mechanisms of action and data from previous studies in RRMS suggest the effect of laquinimod is focused on the neurodegenerative aspects of the disease, which are pervasive in PPMS. We are hopeful that the ARPEGGIO study will demonstrate the ability of laquinimod to slow disability progression in PPMS and fulfill an unmet need for patients with this lifelong and debilitating disease."

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 US, Canada, and Europe.

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 programme 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.

Teva Pharmaceutical Industries Ltd.  is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day.

Active Biotech AB (publ) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer.