Amarin Corporation plc (NASDAQSC: AMRN) today announced positive data analysis from two exploratory phase IIa clinical studies using Miraxion (formerly referred to as LAX-101c) to treat depression. An analysis of the data from the two studies identifies a significant clinical benefit with Miraxion for a sub-group of patients with specific symptomology.
In a recent exploratory phase IIa study, Miraxion was used as monotherapy in 77 patients with a new episode of depression in a six-week trial. In this study it was prespecified, that the presence of specific depression symptomology (patients with melancholic vegetative symptoms) at the time of entry to the study (baseline), would predict response. In an exploratory analysis the Bech-Depression Scale, a subscale of the Hamilton Depression Rating Scale, which defines the affective core symptoms of depression, was used as the outcome variable. Miraxion achieved statistical significance over placebo in the sub-group of patients meeting these criteria.
Miraxion (formerly LAX-101) is a semi-synthetic, highly purified derivative of the n-3 fatty acid eicosapentaenoate (EPA). The mechanism of action is believed to involve stabilization of mitochondrial integrity of suffering neurons, thereby preventing or slowing progression from neuronal dysfunction to apoptosis.
Two Phase II clinical trials have been conducted with Miraxion in treatment-unresponsive depression that concluded with statistical significance that a 1-gram per day dose of Miraxion was effective in treating depression in patients who remained depressed despite receiving standard therapy. The results of these trials were published in the Archives of General Psychiatry in October 2002 and the American Journal of Psychiatry in March 2002.
It's exciting to hear about a new antidepressant under development. I expect few new developments with antidepressants that target the traditional neurotransmitters (serotonin, norepinephrine, dopamine). It will be interesting to see if Omega-3 fatty acids (like Miraxion) and glucocorticoid receptor antagonists turn out to be effective antidepressants.