Jan 12 2005
Amarin Corporation 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.
In addition, using identical symptom-specific methodology, statistically significant results were obtained by reanalyzing the dataset from a published (Peet and Horrobin, 2002, Archives of General Psychiatry, volume 59, pages 913-919) randomized placebo controlled study in treatment unresponsive depression, where Miraxion was used as an adjunct therapy with standard depression treatments.
It is estimated that depressed patients with these symptoms may represent approximately 20-30% of all patients with depression.
Amarin filed a patent covering this intellectual property in late 2004 and intends to publish the full results from the monotherapy study later this year.
Rick Stewart, Chief Executive Officer of Amarin commented, "The data analyzed from these studies show significant clinical benefit for a specific sub-group of patients with depression, when used as either monotherapy or as adjunct therapy. This data will be an important component in the design of subsequent clinical trials. It will allow us to more accurately target patients with depression that may respond to Miraxion."