First patient enrolled in Phase II study evaluating laquinimod for primary progressive MS

Teva and Active Biotech have announced the first patient has been enrolled in the ARPEGGIO study, 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% of all MS patients and is characterised 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.

Hopes that study will demonstrate ability of laquinimod to slow disability progression in PPMS

“Laquinimod may represent an opportunity to help meet the challenge of PPMS,” saidMichael 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, randomised, 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., Canada, and Europe.