FDA requests additional study for Amarin’s Miraxion

Since the most recent update on Miraxion to treat Huntington’s disease (HD) on August 1, 2007, the company has continued a comprehensive analysis of all clinical data with its advisors. This additional analysis supports the preliminary findings, suggesting a clinical benefit from a longer treatment period for Miraxion.

Amarin said that its most recent trial, conducted by the Huntington Study Group in the US and Canada in 316 patients, was a six-month, double-blind placebo controlled study followed by a further six-month extension period where all patients received 2g per day of Miraxion. The primary endpoint was the six-month change in TMS-4, a scale that measures motor symptoms. However, at the six-month time point, there was no statistically significant difference in efficacy between the Miraxion group and the placebo group.

Analysis of the 12-month data showed a statistically significant difference in TMS-4 between the long-term Miraxion group (12-months treatment) and those patients who had switched to Miraxion at six-months. Treatment codes were not broken at the switching point so investigators and patients remained blinded to receipt of Miraxion or placebo in the initial six-month period.

These results suggest that there is benefit from a longer treatment period with Miraxion and are consistent with the 24-month open-label data from the earlier 135-patient trial completed in 2003.

Rick Stewart, CEO of Amarin, said: “We are pleased with the results of the comprehensive clinical data review and are encouraged by the outcome of our recent dialogue with the FDA. We are now in discussions with the Huntington Study Group to determine the optimal design of such a single Phase III trial. We are also considering whether Amarin will conduct this study itself or seek a collaborative partner with which to advance Miraxion in Huntington’s disease.”