Active Biotech drug, laquinimod has failed a phase II trial in primary progressive MS.
Laquinimod a once-daily oral drug targets neurodegeneration and inflammation with a novel mechanism of action being developed for the treatment of relapsing remitting MS (RRMS), primary-progressive MS (PPMS) and Huntington disease.
The PPMS study failed to meet its primary endpoint of brain atrophy as defined by per cent brain volume change (PBVC) from baseline to week 48 after daily oral doses with 0.6mg laquinimod.
The secondary endpoint of time to confirmed disability progression was also not met. There was, however, a reduction in new T2 lesions observed in patients treated with laquinimod 0.6mg. Both endpoints were assessed by MRI analysis.
The ARPEGGIO study is a multinational, multicentre, randomised, double-blind, parallel-group, placebo-controlled, phase II trial evaluating the efficacy, safety and tolerability of laquinimod at 0.6 and 1.5mg per day in patients with PPMS. However, the higher-dose (1.5mg) arm of the trial was discontinued in January 2016.
The clinical safety profile of laquinimod 0.6mg daily in PPMS patients resembled the safety profile demonstrated in relapsing remitting MS patients. The most common adverse events reported by patients treated with laquinimod 0.6mg daily were nasopharyngities, headache, upper respiratory tract infection and back pain.
In a statement Active Biotech said data from the trial will be presented at a future scientific conference and the full results will be published.