Amarin begins European phase 3 trial of Miraxion in Huntington's disease

By E. Janene Geiss

Philadelphia, Dec. 15 - Amarin Corp. plc announced Thursday that the European phase 3 clinical trial of Miraxion in Huntington's disease has started.

The U.S. phase 3 trial started dosing in September, according to a company news release.

"The commencement of the 240 patient European phase 3 clinical trial in Huntington's disease is a major milestone for Amarin. The U.S. trial of 300 patients is now well underway and we expect the European trial will show similar positive progress as patient enrollment accelerates," said Rick Stewart, chief executive officer, in the release.

Miraxion has orphan drug designation in the United States and Europe and has fast-track designation from the Food and Drug Administration for review of the New Drug Application.

The U.S. and European trials are multi-center, randomized, double-blind, placebo-controlled studies at 43 sites in the United States and up to 33 sites in Europe.

The trials are planned to enroll 540 Huntington's disease patients with about 300 in the United States phase 3 trial and about 240 in the European phase 3 trial over a six-month period. Patients in the U.S. trial will participate in a further six-month extension period, officials said.

The primary endpoint of the trials will be to determine whether Miraxion taken 2 grams per day (1 gram twice daily) results in clinically and statistically significant changes in the Total Motor Score-4 subscale of the Unified Huntington's Disease Rating Scale.

The Huntington Study Group, based at the University of Rochester, is conducting the U.S. clinical trial on behalf of Amarin.

The group is a non-profit group of physicians and other health care providers from medical centers in the United States, Canada, Europe and Australia experienced in the care of Huntington's disease patients and dedicated to clinical research of Huntington's disease.

The European clinical trial is being conducted in collaboration with EURO-HD and ICON, a leading contract research organization. EURO-HD is a non-profit group of physicians and other health care professionals dedicated to the research and care of Huntington's disease patients.

Amarin is a London neuroscience company focused on the development and commercialization of novel drugs for the treatment of central nervous system disorders.

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