Amarin gets go ahead for Ph IIa trial of AAMI drug

UK-based drugmaker Amarin Corp has received the necessary regulatory and ethical approvals to commence a Phase IIa trial in age-associated memory impairment with AMR101 (ultra-pure ethyl-EPA).

The Phase IIa trial will be a randomized, double-blind, placebo-controlled study that will enroll 96 patients with AAMI who will be assigned to receive 1g, 2g or 4g of AMR101 or placebo twice daily over a six-week period. Efficacy will be assessed by a computerized battery of cognition tests designed by Cognitive Drug Research. The study is being conducted in the UK and patient recruitment is expected to commence shortly, with initial results expected in the second half of 2008.

Declan Doogan, head of R&D at Amarin, said: "AMR101 has already demonstrated promising positive effects in classical preclinical models of memory and cognition." According to the firm, AAMI is a recognized syndrome relating to memory changes associated with normal aging that is common in individuals over 50 years of age. In the USA, it is estimated that approximately 40% of people aged 65 and above, or 16 million, have AAMI. It is characterized by gradual memory impairment with the absence of dementia. Individuals with AAMI have been shown to have a three-fold greater risk for development of dementia than those who do not meet this criterion, the firm noted.