The final report of the Phase II study of laquinimod, which was successfully concluded in September 2003, has been published last week in Neurology ("Treatment with laquinimod reduces development of active MRI lesions in relapsing MS" by C. Polman, F. Barkhof, M. Sandberg-Wollheim, A. Linde, O. Nordle and T. Nederman." Neurology 2005; vol.64, No.6 p. 987), Teva Pharmaceutical Industries Ltd and Active Biotech AB jointly announced here.

Laquinimod is a novel immunomodulatory substance developed by Active Biotech. It has the potential to be the first orally-available disease modifying treatment for multiple sclerosis (MS).

In June 2004, Teva and Active Biotech signed an agreement for the future global development and commercialization of laquinimod.

The objective of the concluded Phase II study was to evaluate, in relapsing MS patients, the efficacy of 2 doses of laquinimod compared to placebo, based on its ability to suppress the development of active MRI lesions, as well as its safety and tolerability. It was concluded that daily treatment with laquinimod at a dose of 0.3 mg, reduced the mean cumulative number of active lesions by 44 per cent compared to placebo (p<0.05) Its safety profile was very favourable; there were no clinical signs of undesired inflammatory manifestations, the Teva release said here.

Currently, additional Phase II studies are ongoing, aimed at evaluating the benefit of higher doses of laquinimod.