Amarin completes Ph III Miraxion trials

Nasdaq-listed UK drugmaker Amarin has completed the treatment stage of both the North American and European Phase III clinical trials of Miraxion (eicosapentaenoic acid), its drug candidate for the treatment of Huntington's disease.

The multicenter, randomized, double-blind, placebo-controlled trials involved over 600 patients, making it the largest clinical program in HD ever undertaken. Following data validation and analysis, the company expects to report top-line results in the middle of second-quarter 2007.

The primary endpoint of the trials is a change in the Total Motor Score 4 component of the Unified Huntington's Disease Rating Scale, while secondary endpoints include cognition, behavioral and Total Functional Capacity outcomes. Patients in the trial were randomized to receive either placebo or 2g (1g twice daily) of Miraxion for a period of six months. Amarin noted that HD is an ultimately fatal genetic disease causing uncontrolled movements, loss of intellectual faculties, emotional disturbances, psychosis and dementia, for which there are limited treatment options.