Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Amarin Corporation and the FDA have agreed upon the design of two pivotal phase III clinical trials of the company's drug Miraxion for the treatment of Huntington's disease.
Subscribe to our email newsletter
The agreement has been reached under the special protol assessment procedure, a process under which the FDA provides evaluation and guidance on clinical trial protocols for phase III trials.
The trials will take place at 43 sites in the US and up to 28 sites in Europe. They are expected to involve a total of up to 540 Huntington’s disease patients with approximately 300 in the US phase III trial and approximately 240 in the European phase III trial over a six-month period. Patients in the US trial will participate in a further six-month extension period.
The primary endpoint of the trials will be to determine whether Miraxion taken 2g per day (1g twice daily) results in clinically and statistically significant changes in the total motor score-4 subscale of the unified Huntington’s disease rating scale (UHDRS).
Rick Stewart, CEO of Amarin, commented; “Reaching agreement with the FDA on the trial designs is a positive development for Amarin. This is a major milestone for the company and we look forward to immediate enrollment in the US trial.”
The Huntington Study Group (HSG), based at the University of Rochester in New York, will conduct the US clinical trial on behalf of Amarin.