Amarin Shares Down

Press release at FierceBiotech: 

Amarin Corporation Says Huntington's Disease Drug Failed in Trials

LONDON, April 24 -- Amarin Corporation plc ("Amarin" or the "Company") today announces top-line results from its two Phase III clinical trials of Miraxion to treat Huntington's disease (HD). The Company conducted two Phase III double-blind, placebo-controlled studies in which HD patients were randomized to receive either placebo or 2 grams (1 gram twice daily) of Miraxion daily for six months. Study data showed no statistically significant difference in either study between Miraxion and placebo with regard to the primary and secondary endpoints.

These top-line findings are inconsistent with earlier clinical trial data that showed statistical significance in a subset of HD patients with a CAG repeat length of less than or equal to 44.

The primary endpoint of the trials was a change in the Total Motor Score 4 (TMS-4) component of the Unified Huntington's Disease Rating Scale (UHDRS). TMS-4 has been shown to be a sensitive measure of movement disorder in patients with HD. In addition, secondary endpoints included cognition and Total Functional Capacity outcomes. Miraxion was found to be safe and well-tolerated by patients.

Commenting on today's announcement, Rick Stewart, Chief Executive Officer of Amarin, said, "We are extremely surprised and disappointed by these top-line results, and we are analyzing the data in order to better understand the full and complete data set and outcomes. We are particularly disappointed that, at this time, we are not in a position to bring any positive news to those patients who are suffering from this devastating disease and to the broader HD community."