Israeli drugmaker Teva and Swedish pharmaceutical firm Active Biotech have enrolled the first patient in a Phase II trial (ARPEGGIO) of laquinimod, an investigational, oral, immune modulator, to treat primary progressive multiple sclerosis (PPMS).
Laquinimod is a once-daily oral, CNS-active immunomodulator with a new mechanism of action under development to treat relapsing-remitting MS (RRMS), progressive MS and Huntington's disease (HD).
PPMS represents a condition with a high unmet need affecting around 15% of all MS patients and currently it has no approved treatments. It is characterised by the worsening of neurologic function without distinct relapses also called attacks or exacerbations.
Teva Global R&D president and chief scientific officer Michael Hayden said: "Laquinimod may represent an opportunity to help meet the challenge of PPMS.
"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."
Around 375 patients in the US, Canada and Europe will be enrolled in the multinational, multicenter, randomised, double-blind, parallel-group, placebo-controlled ARPEGGIO trial, which will evaluate the once-daily, oral laquinimod 0.6mg or 1.5mg/day in PPMS patients.
Primary endpoint of the trial is percent brain volume change (PBVC) through MRI analysis.
The global Phase III clinical development programme in MS includes two completed pivotal trials, ALLEGRO and BRAVO both using laquinimod 0.6mg/day.
The third Phase III trial, CONCERTO, is currently ongoing and evaluating two doses of laquinimod 0.6mg and 1.2mg/day in around 2,100 patients for up to 24 months.
Image: Photomicrograph of a demyelinating MS-Lesion. Photo: courtesy of Marvin 101.